A Phase 2 interventional study of Azithromycin plus chloroquine in Falciparum Malaria, sponsored by Pfizer. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 110 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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Exclusion Criteria:
Single Arm, Open label study
Drug: Azithromycin plus chloroquine
dose of 2000 mg Azithromycin plus 600 mg chloroquine base
Percentage of Participants With Parasite Clearance at Day 28
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
Time frame: Day 28
Percentage of Participants With Early Treatment Failures (ETF)
ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness \[for example, obtundation, unarousable coma, delirium, stupor\], respiratory distress \[respiratory rate greater than or equal to {\>=} 30 breaths/minute\], seizures, hypoglycemia \[glucose less than or equal to {\<=} 40 milligram/deciliter\], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 \> Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 \> 37.5 degrees Celsius (axillary temperature) and \>38 degrees Celsius (oral temperature) and parasite count on Day 3 \>=25 percent (%) of the first available parasite density on Day 0 (baseline).
Time frame: Baseline up to Day 28
Percentage of Participants With Late Treatment Failures (LTF)
LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.
Time frame: Baseline up to Day 28
Percentage of Participants With Resistance to Treatment
Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (\<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (\>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Clinical Cure
Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).
Time frame: Day 3, 7, 28, and 42
Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
Time frame: Day 7, 14, 21, 35, 42
Percentage of Participants With Gametocyte Clearance
Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.
Time frame: Day 7, 14, 21, 28, 35, 42
Fever Clearance Time
Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (\<) 37.5 degree Celsius (C) (axillary temperature) or \<38 degree C (oral temperature).
Time frame: Baseline up to Day 42
Parasite Clearance Time
Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.
Time frame: Baseline up to Day 42
| Milestone | Azithromycin and Chloroquine |
|---|---|
| Started | 110 |
| Completed | 103 |
| Not completed | 7 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Asymptomatic parasitemia | 2 |
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Percentage of Participants With Parasite Clearance at Day 28 | 97.20 (94.09 to 100.00) |
ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness \[for example, obtundation, unarousable coma, delirium, stupor\], respiratory distress \[respiratory rate greater than or equal to {\>=} 30 breaths/minute\], seizures, hypoglycemia \[glucose less than or equal to {\<=} 40 milligram/deciliter\], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 \> Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 \> 37.5 degrees Celsius (axillary temperature) and \>38 degrees Celsius (oral temperature) and parasite count on Day 3 \>=25 percent (%) of the first available parasite density on Day 0 (baseline).
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Percentage of Participants With Early Treatment Failures (ETF) | 0 (-0.47 to 0.47) |
LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Percentage of Participants With Late Treatment Failures (LTF) | 2.80 (-0.3 to NA) |
Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (\<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (\>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Day 7 (n=109) | 22.02 |
| Day 14 (n=109) | 22.02 |
| Day 21 (n=107) | 22.43 |
| Day 28 (n=107) | 24.3 |
| Day 35 (n=107) | 25.23 |
| Day 42 (n=107) | 25.23 |
Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Day 3 | 100.00 (99.54 to 100.0) |
| Day 7 | 100.00 (99.54 to 100.0) |
| Day 28 | 96.33 (92.90 to 99.77) |
| Day 42 | 96.33 (92.90 to 99.77) |
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Day 7 (n=109) | 100.00 (99.54 to 100.00) |
| Day 14 (n=109) | 100.00 (99.54 to 100.00) |
| Day 21 (n=107) | 99.07 (97.06 to 100.00) |
| Day 35 (n=107) | 96.26 (92.76 to 99.76) |
| Day 42 (n=107) | 96.26 (92.76 to 99.76) |
Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.
| percentage of participants | Azithromycin and Chloroquine |
|---|---|
| Day 7 (n=109) | 84.40 (78.20 to 90.61) |
| Day 14 (n=109) | 81.65 (75.07 to 88.24) |
| Day 21 (n=106) | 77.35 (70.17 to 84.55) |
| Day 28 (n=105) | 76.19 (68.84 to 83.54) |
| Day 35 (n=103) | 76.69 (69.33 to 84.07) |
| Day 42 (n=104) | 76.92 (69.61 to 84.23) |
Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (\<) 37.5 degree Celsius (C) (axillary temperature) or \<38 degree C (oral temperature).
No measurements were reported for this outcome.
Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin and Chloroquine | — | 0/110 (0%) | 54/110 (49.1%) |
| Event | Azithromycin and Chloroquine |
|---|---|
| NauseaGastrointestinal disorders | 36/110 |
| VomitingGastrointestinal disorders | 22/110 |
| DiarrhoeaGastrointestinal disorders | 13/110 |
| DehydrationMetabolism and nutrition disorders | 6/110 |
| GastritisGastrointestinal disorders | 4/110 |
| PruritusSkin and subcutaneous tissue disorders | 4/110 |
| Back painMusculoskeletal and connective tissue disorders | 2/110 |
| AnaemiaBlood and lymphatic system disorders | 1/110 |
| TachycardiaCardiac disorders | 1/110 |
| PainGeneral disorders | 1/110 |
All treated population included participants who received at least 1 dose of study medication.
| Age, Continuous(years) | Azithromycin and Chloroquine |
|---|---|
| Mean | 30.8 ± 13.0 |
| Sex: Female, Male(Participants) | Azithromycin and Chloroquine |
|---|---|
| Female | 25 |
| Male | 85 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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