Status:
COMPLETED
Triple Combinations Against Hookworm Infections in Lao
Lead Sponsor:
Swiss Tropical & Public Health Institute
Conditions:
Hookworm Infection
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
Brief 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-ris...
Detailed Description
More than one billion people are infected with A. lumbricoides, hookworm or Trichuris trichiura, the so-called soil-transmitted helminths (STH). Preventive chemotherapy - i.e. annual or biannual treat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT03278431
Start Date
September 27 2017
End Date
December 1 2017
Last Update
May 8 2018
Active Locations (1)
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1
Nambak District Hospital
Luang Prabang, Laos, 0604