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TerminatedNCT01103713Updated Jan 26, 2015Results posted

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

A Phase 3 interventional study of Azithromycin plus chloroquine in Asymptomatic Parasitemia In Pregnancy, sponsored by Pfizer. Terminated at 7 sites in 5 countries. Open to female participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Why this study was terminated
See termination reason in detailed description.
Phase
Phase 3
Study type
Interventional
Enrollment
168
Allocation
Non-randomized
Ages
16 Years to 35 Years
Sex
Female
01

Study summary

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

Read the detailed description

After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

02

Conditions studied

  • Asymptomatic Parasitemia In Pregnancy

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Keywords

  • P. falciparum malaria
  • asymptomatic parasitemia
  • parasitological clearance
  • Intermittent Preventive Treatment of Falciparum Malaria in Pregnant Women (IPTp)
03

In context

Parasitemia

22 studies on the registry are indexed under Parasitemia; 1 is open to participants now.

This study's enrollment of 168 is above the median of 60 across 14 interventional studies indexed under Parasitemia.

Browse Parasitemia studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primigravidae and secundigravidae pregnant women at >=14 and \<=30 weeks of gestational age (confirmed by ultrasound examination).
  • Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80 100,000/uL on thick blood smears.
  • Evidence of a personally signed and dated document indicating that the subject (or a legally acceptable representative if a subject is \<18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects \<18 years of age.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Age \<16 years old or >35 years old.
  • Multiple gestations (more than one fetus) as per the ultrasound results at screening.
  • Clinical symptoms of malaria.
  • \<8 g/dL (measured at baseline).
  • Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
  • Use of antimalarial drugs in previous 4 weeks.
  • History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
  • Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or sulphonamides.
  • Requirement to use medication during the study that might interfere with the evaluation of the study drug of AZ or CQ or is contra indicated during pregnancy per package inserts.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
  • Known severe sickle cell (SS) disease or sickle hemoglobin C (SC) anemia.
  • Known family history of prolonged syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    AZCQ

    Azithromycin/Chloroquine

    Drug: Azithromycin plus chloroquine

Interventions

  • DrugAzithromycin plus chloroquine

    Drug pages: Azithromycin · Chloroquine

    Study drug is a fixed dose tablet of AZCQ containing 250 mg AZ and 155 mg CQ base. All subjects will be administered a 3 day course of AZCQ IPTp regimen: a single dose of 1000 mg AZ/620 mg CQ base (4 fixed dose combination tablets of AZCQ: 250mg/155mg) administered per os (PO, orally) once daily for 3 days (Days 0, 1, 2).

    Also known as: Zithromax; Aralen

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Day 28

  2. Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Day 28

Secondary outcomes

  1. Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Days 7, 14, 21, 35, and 42

  2. Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Days 7, 14, 21, 35, and 42

  3. Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Days 7, 14, 21, 28, 35, and 42

  4. Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

    The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.

    Time frame: Days 7, 14, 21, 28, 35, and 42

  5. Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

    Parasite counts (actual counts per microliter of blood) was measured at various time points.

    Time frame: Days 7, 14, 21, 28, 35, and 42

Other outcomes

  1. Summary of Pregnancy Outcome: Location of Delivery

    All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  2. Summary of Pregnancy Outcome: Mode of Delivery

    All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  3. Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?

    All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  4. Summary of Pregnancy Outcome: Labor Induced?

    All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  5. Summary of Pregnancy Outcome: Complications During Delivery?

    All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  6. Summary of Pregnancy Outcome: Outcome of Birth

    All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

    Time frame: Following delivery or pregnancy termination

  7. Incidence of Fever Based on Oral Temperature

    Oral temp was taken by the fieldworker through Day 42.

    Time frame: Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42

  8. Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level

    Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value \<0.8 times lower limit of normal was considered clinically significant.

    Time frame: Day 42

  9. Summary of Serum Azithromycin Concentration Versus Time

    AZ concentrations in the serum was determined at specified time points as PK endpoints

    Time frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation.

  10. Summary of Plasma Chloroquine Concentration Versus Time

    CQ concentrations in the plasma were determined at specified time points as PK endpoints

    Time frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.

  11. Summary of Plasma Desethylchloroquine Concentration Versus Time

    CQ concentrations in the plasma were determined at specified time points as PK endpoints

    Time frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.

07

Results

Posted Jan 26, 2015

Participant flow

Participants were enrolled at 5 active sites in 5 countries: Benin (site 1012), Kenya (site 1004), Malawi (site 1015), Tanzania (site 1008), and Uganda (site 1013). The enrollment of the first participant took place on 07 March 2011 and the last participant last visit was on 25 October 2013.

Participant flow — Overall Study
MilestoneAzithromycin (AZ)/Chloroquine (CQ)
Started168
Completed155
Not completed13
Withdrew: Lost to follow-up2
Withdrew: Withdrawal by subject8
Withdrew: Study terminated by sponsor2
Withdrew: Other1

Outcome measures

PrimaryPercentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Day 28
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication99.35 (97.76 to 100.00)
PrimaryPercentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Day 28
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication99.35 (97.76 to 100.00)
SecondaryPercentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Percentage of participantsAzithromycin/Chloroquine (AZCQ)
Day 7 (n=156)100 (97.66 to 100.00)
Day 14 (n=154)100 (97.63 to 100.00)
Day 21 (n=154)100 (97.63 to 100.00)
Day 35 (n=148)96.65 (93.42 to 99.87)
Day 42 (n=138)95.19 (91.35 to 99.03)
SecondaryPercentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=156)100.00 (97.66 to 100.00)
Day 14 (n=154)100.00 (97.63 to 100.00)
Day 21 (n=154)100.00 (97.63 to 100.00)
Day 35 (n=148)96.65 (93.42 to 99.87)
Day 42 (n=138)95.19 (91.35 to 99.03)
SecondaryPercentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=158)100.00 (97.69 to 100.00)
Day 14 (n=156)100.00 (97.66 to 100.00)
Day 21 (n=156)100.00 (97.66 to 100.00)
Day 28 (n=156)99.36 (97.79 to 100.00)
Day 35 (n=150)96.69 (93.51 to 99.88)
Day 42 (n=140)95.26 (91.47 to 99.05)
SecondaryPercentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=156)100.00 (97.66 to 100.00)
Day 14 (n=154)100.00 (97.63 to 100.00)
Day 21 (n=154)100.00 (97.63 to 100.00)
Day 28 (n=154)95.45 (91.84 to 99.07)
Day 35 (n=154)87.66 (82.14 to 93.18)
Day 42 (n=152)78.43 (71.59 to 85.28)
SecondaryPercentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=156)100.00 (97.66 to 100.00)
Day 14 (n=154)100.00 (97.63 to 100.00)
Day 21 (n=154)100.00 (97.63 to 100.00)
Day 28 (n=154)95.45 (91.84 to 99.07)
Day 35 (n=154)87.66 (82.14 to 93.18)
Day 42 (n=152)78.43 (71.59 to 85.28)
SecondaryPercentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Number · Percentage of participants
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Percentage of participantsAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=158)100.00 (97.69 to 100.00)
Day 14 (n=156)100.00 (97.66 to 100.00)
Day 21 (n=156)100.00 (97.66 to 100.00)
Day 28 (n=156)95.51 (91.94 to 99.08)
Day 35 (n=156)87.82 (82.37 to 93.27)
Day 42 (n=154)78.71 (71.94 to 85.48)
SecondaryNumber of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

Parasite counts (actual counts per microliter of blood) was measured at various time points.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Mean · Parasite count per microliter
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Parasite count per microliterAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=155)0.00 ± 0.00
Day 14 (n=154)0.00 ± 0.00
Day 21 (n=156)0.00 ± 0.00
Day 28 (n=156)216.91 ± 110.04
Day 35 (n=156)555.36 ± 246.77
Day 42 (n=155)907.88 ± 470.82
SecondaryNumber of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

Parasite counts (actual counts per microliter of blood) was measured at various time points.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Mean · Parasite count per microliter
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Parasite count per microliterAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=153)0.00 ± 0.00
Day 14 (n=152)0.00 ± 0.00
Day 21 (n=154)0.00 ± 0.00
Day 28 (n=154)219.73 ± 111.46
Day 35 (n=154)562.57 ± 249.94
Day 42 (n=153)919.75 ± 476.92
SecondaryNumber of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication

Parasite counts (actual counts per microliter of blood) was measured at various time points.

Time frame:
Days 7, 14, 21, 28, 35, and 42
Reported as:
Mean · Parasite count per microliter
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Parasite count per microliterAzithromycin (AZ)/Chloroquine (CQ)
Day 7 (n=153)0.00 ± 0.00
Day 14 (n=152)0.00 ± 0.00
Day 21 (n=154)0.00 ± 0.00
Day 28 (n=154)219.73 ± 111.46
Day 35 (n=154)562.57 ± 249.94
Day 42 (n=153)919.75 ± 476.92
Other pre-specifiedSummary of Pregnancy Outcome: Location of Delivery

All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Location of Delivery
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Medical facility130
Home27
Other (Not specified)3
Other pre-specifiedSummary of Pregnancy Outcome: Mode of Delivery

All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Mode of Delivery
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Vaginal145
Cesarean section15
Other pre-specifiedSummary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?

All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Yes132
No27
Other pre-specifiedSummary of Pregnancy Outcome: Labor Induced?

All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Labor Induced?
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Yes3
No155
Other pre-specifiedSummary of Pregnancy Outcome: Complications During Delivery?

All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Complications During Delivery?
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Yes42
No117
Other pre-specifiedSummary of Pregnancy Outcome: Outcome of Birth

All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.

Time frame:
Following delivery or pregnancy termination
Reported as:
Number · Participants
Summary of Pregnancy Outcome: Outcome of Birth
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Full term live birth151
Premature birth6
Stillbirth3
Spontaneous abortion0
Induced/elective abortion0
Other pre-specifiedIncidence of Fever Based on Oral Temperature

Oral temp was taken by the fieldworker through Day 42.

Time frame:
Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42
Reported as:
Number · Participants
Incidence of Fever Based on Oral Temperature
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Baseline (n=165)0
Day 1 (n=161)0
Day 2 (n=160)0
Day 7 (n=156)0
Day 14 (n=155)0
Day 21 (n=155)0
Day 28 (n=156)0
Day 35 (n=156)0
Day 42 (n=155)4
Other pre-specifiedSummary of Hemoglobin Concentration: Abnormal Hemoglobin Level

Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value \<0.8 times lower limit of normal was considered clinically significant.

Time frame:
Day 42
Reported as:
Number · Participants
Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level
ParticipantsAzithromycin (AZ)/Chloroquine (CQ)
Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level1
Other pre-specifiedSummary of Serum Azithromycin Concentration Versus Time

AZ concentrations in the serum was determined at specified time points as PK endpoints

Time frame:
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation.
Reported as:
Mean · ng/ml
Summary of Serum Azithromycin Concentration Versus Time
ng/mlAzithromycin (AZ)/Chloroquine (CQ)
Hour 0 (Day 0) (n=161)NA ± NA
Hour 48 (Day 2) (n=158)194.145 ± 63.76829
Hour 50 (Day 2) (n=147)994.463 ± 552.23738
Hour 56 (Day 2) (n=159)707.682 ± 326.72379
Hour 168 (Day 7) (n=155)54.444 ± 24.34615
Hour 336 (Day 14) (n=153)20.307 ± 31.57879
Other pre-specifiedSummary of Plasma Chloroquine Concentration Versus Time

CQ concentrations in the plasma were determined at specified time points as PK endpoints

Time frame:
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.
Reported as:
Mean · ng/ml
Summary of Plasma Chloroquine Concentration Versus Time
ng/mlAzithromycin (AZ)/Chloroquine (CQ)
Hour 0 (Day 0) (n=160)NA ± NA
Hour 48 (Day 2) (n=158)305.827 ± 129.02771
Hour 50 (Day 2) (n=147)621.134 ± 329.92731
Hour 56 (Day 2) (n=159)640.679 ± 297.97628
Hour 168 (Day 7) (n=155)129.835 ± 92.19161
Hour 336 (Day 14) (n=154)43.119 ± 44.97312
Hour 504 (Day 21) (n=156)22.382 ± 46.83029
Hour 672 (Day 28) (n=156)12.721 ± 29.05380
Other pre-specifiedSummary of Plasma Desethylchloroquine Concentration Versus Time

CQ concentrations in the plasma were determined at specified time points as PK endpoints

Time frame:
Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.
Reported as:
Mean · ng/ml
Summary of Plasma Desethylchloroquine Concentration Versus Time
ng/mlAzithromycin (AZ)/Chloroquine (CQ)
Hour 0 (Day 0) (n=158)NA ± NA
Hour 48 (Day 2) (n=158)183.622 ± 118.86488
Hour 50 (Day 2) (n=147)220.424 ± 130.48349
Hour 56 (Day 2) (n=159)241.831 ± 137.88581
Hour 168 (Day 7) (n=155)144.088 ± 123.66303
Hour 336 (Day 14) (n=154)55.513 ± 54.78967
Hour 504 (Day 21) (n=156)29.825 ± 32.41800
Hour 672 (Day 28) (n=156)19.439 ± 19.52079

Adverse events

Collected over Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Azithromycin/Chloroquine (Familial Status = Neonate)—9/157 (5.7%)20/157 (12.7%)
Azithromycin/Chloroquine (Familial Status = Mother)—0/168 (0%)92/168 (54.8%)
Most frequent serious events
Most frequent serious events
EventAzithromycin/Chloroquine (Familial Status = Neonate)Azithromycin/Chloroquine (Familial Status = Mother)
Neonatal asphyxiaRespiratory, thoracic and mediastinal disorders4/157—
HypospadiasCongenital, familial and genetic disorders1/157—
PolydactylyCongenital, familial and genetic disorders1/157—
Sudden infant death syndromeGeneral disorders1/157—
Sepsis neonatalInfections and infestations1/157—
Premature babyPregnancy, puerperium and perinatal conditions1/157—
Most frequent other events
Showing 10 of 37
Most frequent other events
EventAzithromycin/Chloroquine (Familial Status = Neonate)Azithromycin/Chloroquine (Familial Status = Mother)
VomitingGastrointestinal disorders0/15735/168
DizzinessNervous system disorders0/15733/168
PruritusSkin and subcutaneous tissue disorders0/15713/168
Infection parasiticInfections and infestations0/15712/168
HeadacheNervous system disorders0/15710/168
Pruritus generalisedSkin and subcutaneous tissue disorders0/1579/168
Low birth weight babyPregnancy, puerperium and perinatal conditions8/1570/168
MalariaInfections and infestations0/1578/168
FatigueGeneral disorders0/1577/168
Upper respiratory tract infectionInfections and infestations3/1577/168

Baseline characteristics

Age, Customized
Age, Customized(Participants)Azithromycin (AZ)/Chloroquine (CQ)
<16 years0
16-17 years41
18-25 years125
26-30 years1
31-35 years1
>35 years0
Sex: Female, Male
Sex: Female, Male(Participants)Azithromycin (AZ)/Chloroquine (CQ)
Female168
Male0
08

Study locations

7 sites
  • Centre de Sante d'AHOUANSORI -AGUE
    Cotonou, Benin
  • Hôpital Bethesda
    Cotonou, Benin
  • Siaya District Hospital
    Siaya, Kenya
  • Zomba Central Hospital
    Zomba, Malawi
  • Teule Hospital
    Muheza, Tanga, Tanzania
  • National Institute for Medical Research (Mwanza Centre)/ Nyamagana District Hospital
    Mwanza, 1903, Tanzania
  • Mulanda Health Centre IV
    Kampala, Uganda
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Jun 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2015, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2010
First posted
Apr 15, 2010
Start
Mar 2011
Primary completionActual
Jun 2013
CompletionActual
Oct 2013
Results first posted
Jan 26, 2015
Last update
Jan 26, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01103713
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 15, 2010
Start date
Mar 2011
Primary completion
Jun 2013
Completion
Oct 2013
Results posted
Jan 26, 2015
Last update
Jan 26, 2015

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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