Hookworm Infections Clinical Trial
Official title:
Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial
Verified date | January 2022 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura. The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment. This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).
Status | Completed |
Enrollment | 536 |
Est. completion date | September 22, 2021 |
Est. primary completion date | August 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 19 Years |
Eligibility | Inclusion Criteria: - Aged between 12 and 19 years. - Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 years of age); and written assent by underage participant. - Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (14-21 days, 5-6 weeks and 3 months after treatment). - Willing to be examined by a study physician prior to treatment. - At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 48 EPG. Exclusion Criteria: - No written informed consent by individual or caregiver and/or no written assent by minors - Presence or signs of major systemic illnesses, e.g. body temperature = 38°C, severe anemia (below 80g/l Hb according to WHO) upon initial clinical assessment. - History of acute or severe chronic disease. - Recent use of anthelmintic drug (within past 4 weeks). - Attending other clinical trials during the study. - Pregnancy, lactating, and/or planning to become pregnant within the next 6 months. - Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin). - Taking medication with known interaction on study drugs. |
Country | Name | City | State |
---|---|---|---|
Tanzania | Public Health Laboratory Ivo de Carneri | Chake Chake | Pemba |
Lead Sponsor | Collaborator |
---|---|
Jennifer Keiser | Public Health Laboratory Ivo de Carneri |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Egg reduction rate against T. trichiura | Egg reduction rate calculated from the geometric means of co-administered moxidectin/ albendazole and ivermectin/ albendazole against T. trichiura assessed at 14-21 days post-treatment is the primary endpoint in our study. | 14-21 day post-treatment | |
Secondary | Superiority in terms of cure rates (CRs) | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 µg/kg) and Arm E: Moxidectin (8 mg) | 14-21 day post-treatment | |
Secondary | CRs against T. trichiura | CRs of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 14-21 day post-treatment | |
Secondary | Safety and tolerability | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. | treatment until 3 months post-treatment | |
Secondary | Cure rates and egg reduction rates against concomitant soil-transmitted helminth infections | CRs and ERR will be calculated for Ascaris lumbricoides and hookworm infections.
CRs of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
14-21 days post-treatment | |
Secondary | Extended effects on follow-up helminth prevalence | CRs and ERR will be calculated for T. trichiura, A. lumbricoides and hookworm infections. | 5-6 weeks and 3 months post-treatment | |
Secondary | Diagnostic performance | Comparison of CRs based on egg counts retrieved from novel diagnostic tools (FECPAK-G2 and/or PCR) compared to standard microscopy (Kato-Katz method) | baseline and 14-21 days post-treatment | |
Secondary | Pharmacokinetics and drug-drug interactions | Characterization of population PK parameters, as well as drug-drug interactions of active study treatments following single and co-administration in T. trichiura infected adolescents. If a dose-response is observed, a PK/PD analysis will further be performed | between 0 and 72 hours |
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