Triple Combinations Against Hookworm Infections in Lao

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Tropical & Public Health Institute
• Treatments: Albendazole; DMP 777; Mebendazole; Oxantel; Oxantel pamoate; Piperazine; Piperazine citrate; Pyrantel; Pyrantel Pamoate

Criteria

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)