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CompletedNCT03245398Updated Jun 17, 2019Results posted

Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children

A Phase 4 interventional study of Treatment with one of the two regimens of mebendazole in Hookworm, sponsored by Jennifer Keiser. Completed at 1 site in Tanzania. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Jennifer Keiser · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our primary objective is to assess the efficacy and safety of: i) 100 mg solid tablets twice a day for 3 days, and ii) one dose of 500 mg solid tablets of mebendazole in participants aged 6-12, inclusive, infected with hookworm.

The primary endpoint of the trial is the cure rate (CR) of the 3-day regimen of mebendazole against hookworm and a single dose mebendazole treatment.

The secondary objectives are to determine if the multi-dose regimen is superior to the single dose regimen, evaluate the efficacy against concomitant soil-transmitted helminth infections, and assess the safety of both mebendazole regimens.

After obtaining informed consent from children's caregiver, the medical history of the participating individuals will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Enrollment will be based on two stool samples which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days apart. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.

Randomization of participants into the two treatment arms will be stratified according to intensity of infection. Participants will be interviewed before treatment for clinical symptoms and 3 hours after every morning treatment and 24 hours after every morning treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.

The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, two sensitivity analyses will be conducted imputing all missing endpoint data as treatment failures or all as treatment success. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. CRs will be compared by using unadjusted logistic regression. To assess model robustness with respect to covariates, adjusted logistic regressions (adjustment for age, sex, school, weight and strata) will be performed.

Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for ERRs and the difference of the ERRs.

02

Conditions studied

  • Hookworm

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03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent signed by parents and/or caregiver; and oral assent by participant.
  • Able and willing to be examined by a study physician at the beginning of the study.
  • Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
  • Positive for hookworm eggs in the stool (≥ 100 EPG and at least two Kato-Katz thick smears slides with more than one hookworm egg).
  • Absence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor at school, upon initial clinical assessment.
  • No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease.
  • No recent anthelminthic treatment (within past 4 weeks). No known allergy to study medications (mebendazole and albendazole).

Exclusion criteria

Exclusion Criteria:

No written informed consent by parents and/or caregiver; no oral assent by participant.

  • Menarche, based on self-report
  • Presence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor, upon initial clinical assessment.
  • History of acute or severe chronic disease.
  • Recent use of anthelminthic drug (within past 4 weeks).
  • Attending other clinical trials during the study.
  • Negative diagnostic result for hookworm eggs in the stool (\< 100 EPG (total of the four slides) and/or only one Kato-Katz thick smear slide with more than one hookworm egg).
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
186 participants (actual)

Study arms

  • Active comparator
    Single dose of mebendazole

    In day 1 each child in this treatment arm will receive a 500 mg tablet of mebendazole plus one 100 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the placebo. In day 2 and 3 each child will receive one placebo twice a day (in the morning and in the evening)

    Drug: Treatment with one of the two regimens of mebendazole

  • Active comparator
    Multiple dose of mebendazole

    In day 1 each child in this treatment arm will receive a 100 mg tablet of mebendazole plus one 500 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the 100 mg tablet of mebendazole. In day 2 and 3 each child will receive one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).

    Drug: Treatment with one of the two regimens of mebendazole

Interventions

  • DrugTreatment with one of the two regimens of mebendazole

    Once in the morning and once in the evening for 3 consecutive days

05

What researchers measure

Primary outcomes

  1. Cure Rate (CR) of Mebendazole Against Hookworm

    Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

Secondary outcomes

  1. Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  2. CR of Both Mebendazole Regimens Against Trichuris Trichiura

    Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  3. Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  4. Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides

    Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  5. Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides.

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  6. Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  7. Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

  8. Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

    Time frame: baseline (before treatment) and 18 to 22 days post-treatment

Other outcomes

  1. Comparison of the Sensitivity of Kato Katz to Quantitative Polymerase Chain Reaction (PCR) Assays

    Two aliquots (about 1 g of stool each) of positive samples will be stored in ethanol and transported to the Swiss Tropical Public Health Institute for subsequent DNA extraction and diagnostic.

    Time frame: 1 year

  2. Prevalence of Genetic Resistance Markers Among Participants

    The same two aliquots of stool will be used in this section.. Additionally, a Harada Mori culture will be prepared from one of the stool samples of each child at baseline and at follow-up to extract hatched larvae. Larvae will be stored in ethanol. Both stool and larvae samples will undergo an assessment of drug resistance-associated single-nucleotide polymorphisms.

    Time frame: 2 years

  3. Distribution of Hookworm Species Among Participants

    Genetic differentiation between Necator americanus and Ancylostoma duodenale using PCRs will allow us to identify which of the species is most prevalent.

    Time frame: 1 year

06

Results

Posted Jun 17, 2019

Participant flow

Participant flow — Overall Study
MilestoneSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Started9393
Completed9293
Not completed10
Withdrew: Travelled to another island10

Outcome measures

PrimaryCure Rate (CR) of Mebendazole Against Hookworm

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Number · percentage of participants cured
Cure Rate (CR) of Mebendazole Against Hookworm
percentage of participants curedSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Cure Rate (CR) of Mebendazole Against Hookworm13 (6.9 to 21.7)97.9 (92.4 to 99.7)
SecondaryGeometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Geometric mean · percentage change
Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm
percentage changeSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm-68.0 (-78.6 to -51.5)-100 (-100 to -99.9)
SecondaryCR of Both Mebendazole Regimens Against Trichuris Trichiura

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Number · percentage of participants cured
CR of Both Mebendazole Regimens Against Trichuris Trichiura
percentage of participants curedSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
CR of Both Mebendazole Regimens Against Trichuris Trichiura6.8 (4.6 to 17.8)42.9 (33.8 to 54.8)
SecondaryGeometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Mean · percentage of change
Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura
percentage of changeSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura-71.7 (-78.5 to -56.7)-98.1 (-98.7 to -96.8)
SecondaryCure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides

Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Number · percentage of participants cured
Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides
percentage of participants curedSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides100 (100 to 100)98 (94.2 to 100)
SecondaryGeometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides.

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Mean · percentage change
Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides.
percentage changeSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides.-100 (-100 to -100)-100 (-100 to -100)
SecondaryArithmetic ERR of the Two Regimens of Mebendazole Against Hookworm

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Mean · percentage change
Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm
percentage changeSingle Dose of MebendazoleMultiple Dose of Mebendazole
Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm-52.7 (-63.6 to -40.3)-99.8 (-100 to -99.3)
SecondaryArithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Mean · percentage change
Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura
percentage changeSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura-49.1 (-61.0 to -31.7)-91.6 (-94.6 to -88.4)
SecondaryArithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)\*100).

Time frame:
baseline (before treatment) and 18 to 22 days post-treatment
Reported as:
Mean · percentage change
Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides
percentage changeSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides-100 (-100 to -100)-99.1 (-100 to -96.9)
Other pre-specifiedComparison of the Sensitivity of Kato Katz to Quantitative Polymerase Chain Reaction (PCR) Assays

Two aliquots (about 1 g of stool each) of positive samples will be stored in ethanol and transported to the Swiss Tropical Public Health Institute for subsequent DNA extraction and diagnostic.

Time frame:
1 year

Results for this outcome have not been posted.

Other pre-specifiedPrevalence of Genetic Resistance Markers Among Participants

The same two aliquots of stool will be used in this section.. Additionally, a Harada Mori culture will be prepared from one of the stool samples of each child at baseline and at follow-up to extract hatched larvae. Larvae will be stored in ethanol. Both stool and larvae samples will undergo an assessment of drug resistance-associated single-nucleotide polymorphisms.

Time frame:
2 years

Results for this outcome have not been posted.

Other pre-specifiedDistribution of Hookworm Species Among Participants

Genetic differentiation between Necator americanus and Ancylostoma duodenale using PCRs will allow us to identify which of the species is most prevalent.

Time frame:
1 year

Results for this outcome have not been posted.

Adverse events

Collected over Adverse event data collected 3h after the first treatment time point. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single 500 mg Dose of Mebendazole0/93 (0%)0/93 (0%)2/93 (2.2%)
Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole0/93 (0%)0/93 (0%)8/93 (8.6%)
Most frequent other events
Most frequent other events
EventSingle 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg Mebendazole
Abdominal painGastrointestinal disorders2/938/93

Baseline characteristics

Age, Continuous
Age, Continuous(years)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Mean10.1 ± 1.610.1 ± 1.610.1 ± 1.6
Sex: Female, Male
Sex: Female, Male(Participants)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Female394685
Male5447101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Black9393186
Region of Enrollment
Region of Enrollment(participants)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Tanzania9393186
Mean weight (kg)
Mean weight (kg)(kg)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Mean26.7 ± 5.326.2 ± 5.126.4 ± 5.2
Mean height (cm)
Mean height (cm)(cm)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Mean132.0 ± 10.2131.8 ± 9.6131.9 ± 9.9
Infected with hookworm
Infected with hookworm(Participants)Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Count of participants9393186
Median EPG hookworm
Median EPG hookworm(Eggs per gram (EPG))Single 500 mg Dose of MebendazoleMultiple (Bid for 3 Days) Dose of 100 mg MebendazoleTotal
Median222 (78 to 534)222 (96 to 606)222 (90 to 582)

14 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Public Health Laboratory Ivo de Carneri, P.O. Box 122
    Chake Chake, Pemba, Tanzania
08

References and documents

Publications

  • Palmeirim MS, Ame SM, Ali SM, Hattendorf J, Keiser J. Efficacy and Safety of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial. EClinicalMedicine. 2018 Jul 11;1:7-13. doi: 10.1016/j.eclinm.2018.06.004. eCollection 2018 Jul. PubMed 31193620 ↗

Study documents

  • Protocol, analysis plan and consent form · Jul 17, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03245398
Lead sponsor
Jennifer Keiser
Collaborators
PATH, Public Health Laboratory Ivo de Carneri
Responsible party
Jennifer Keiser (Dr., Swiss Tropical & Public Health Institute) — Sponsor-investigator
First posted
Aug 10, 2017
Start date
Jul 25, 2017
Primary completion
Sep 15, 2017
Completion
Sep 15, 2017
Results posted
Jun 17, 2019
Last update
Jun 17, 2019

Study contacts

Jennifer Keiser, PhD
principal investigator · Swiss Tropical & Public Health Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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