Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03995680

Acronym

CHEW_MEB_PEMBA

Enrollment

397

Registered

2019-06-24

Start date

2019-07-12

Completion date

2019-10-09

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hookworm Infections

Keywords

Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Acceptability

Brief summary

The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.

Interventions

DRUGMebendazole

Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female children aged between 3 and 12 years; * Written informed consent signed by caregiver; * Was examined by a study physician before treatment; * Provided two stool samples at baseline; * Hookworm EPG \> 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;

Exclusion criteria

* Pregnant; * Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment; * Suffers from severe anemia (Hb \< 80 g/l); * Received anthelminthic treatment or metronidazole within past four weeks. * Attending other clinical trials during the study.

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).

Secondary

Measure	Time frame	Description
CR of Both Mebendazole Regimens Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Cure Rate (CR) of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.	Baseline (before treatment) and sometime between 14 and 21 days post-treatment	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).

Countries

Tanzania

Participant flow

Participants by arm

Arm	Count
Chewable Tablet of Mebendazole A single 500 mg dose of the new chewable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	197
Swallowable Tablet of Mebendazole A single 500 mg dose of the standard swallowable mebendazole tablets will be administered to each child in this arm. Mebendazole: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.	196
Total	393

Baseline characteristics

Characteristic	Swallowable Tablet of Mebendazole	Total	Chewable Tablet of Mebendazole
Age, Continuous	9.4 years STANDARD_DEVIATION 2.1	9.3 years STANDARD_DEVIATION 2.1	9.3 years STANDARD_DEVIATION 2
Height	130.8 centimeters STANDARD_DEVIATION 11.6	130.7 centimeters STANDARD_DEVIATION 11.6	130.5 centimeters STANDARD_DEVIATION 11.5
Hemoglobin	123.5 grams per liter STANDARD_DEVIATION 10.7	122.5 grams per liter STANDARD_DEVIATION 10.5	121.5 grams per liter STANDARD_DEVIATION 10.3
Race and Ethnicity Not Collected	—	0 Participants	—
Sex: Female, Male Female	80 Participants	167 Participants	87 Participants
Sex: Female, Male Male	116 Participants	226 Participants	110 Participants
Weight	26.0 kilograms STANDARD_DEVIATION 6.6	25.7 kilograms STANDARD_DEVIATION 6.5	25.4 kilograms STANDARD_DEVIATION 6.3

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 197	0 / 196
other Total, other adverse events	14 / 197	15 / 196
serious Total, serious adverse events	0 / 197	0 / 196

Outcome results

Primary

Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations 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).