Hookworm Infection Clinical Trial
— TricombiOfficial title:
Different Drug Combinations Against Hookworm Infection in School-aged Children in the Lao People's Democratic Republic, a Single Blind, Randomised Controlled Trial
Verified date | May 2018 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
More than one billion people are infected with soil-transmitted helminths (STH, A.
lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or
biannual treatment of at-risk populations with albendazole or mebendazole is the current
strategy against STH. However, the efficacy of both drugs is only moderate against hookworm
and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new
drugs or the combination of different drugs is the way forward.
In this randomised controlled trial, we assess the efficacy (based on cure rates) of
different drug combinations in school-aged children in Lao. 420 hookworm positive children
will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel
pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with
mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline
and follow-up (14-21 days after treatment) and analysed with Kato-Katz.
Status | Completed |
Enrollment | 420 |
Est. completion date | December 1, 2017 |
Est. primary completion date | November 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 15 Years |
Eligibility |
Inclusion Criteria: - Written informed consent signed by parents and/or legal representative; and a verbal assent (children <12 years) or signed assent (children =12 years), according to Lao regulations. - 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 two to three weeks after treatment (follow-up). - Positive for hookworm eggs in the stool. - Absence of major systemic illnesses, e.g. diabetes, severe anemia as assessed by a medical doctor, 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 (e.g. albendazole, mebendazole, pyrantel pamoate, oxantel pamoate). - Negative pregnancy test (girls =12 years) Exclusion Criteria: - No written informed consent by parents and/or legal representative and no verbal assent (children <12 years) or signed assent (children =12 years). - Presence of major systemic illnesses, e.g. diabetes, severe anemia 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. - Positive pregnancy test (girls =12 years) |
Country | Name | City | State |
---|---|---|---|
Lao People's Democratic Republic | Nambak District Hospital | Luang Prabang |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute |
Lao People's Democratic Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rates of three drug combinations | to comparatively assess the efficacy (based on cure rates, CR) i) albendazole-oxantel pamoate, ii) pyrantel pamoate-oxantel pamoate, iii) albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms. | 14-21 days after treatment | |
Secondary | Cure rates against hookworm of the two triple combinations | To assess the CRs against hookworm of albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (proof of concept) | 14-21 days after treatment | |
Secondary | Egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura | Assessing the egg reduction rates (ERR) against hookworm and ERRs and cure rates (CR) against A. lumbricoides and T. trichiura | 14-21 days after treatment | |
Secondary | Incidence of adverse events 3 and 24 hours after treatment | Participants will be interviewed using a standardized questionnaire, before treatment for clinical symptoms and 3 and 24 hours after treatment about the occurrence of adverse events. | 3 and 24 hours after treatment |
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