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Triple Combinations Against Hookworm Infections in Lao (Tricombi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278431
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Keiser, Swiss Tropical & Public Health Institute

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-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.


Condition or disease Intervention/treatment Phase
Hookworm Infection Drug: Albendazole Drug: Pyrantel Pamoate Drug: Oxantel Pamoate Drug: Mebendazole Phase 4

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 treatment of at-risk populations, is the current strategy against STH advocated by the World Health Organization. However, the currently used drugs albendazole and mebendazole have only moderate efficacy against hookworm and low against T. trichiura. The main challenge is their temporal decrease in efficacy, which might be associated with drug resistance, as it was shown in veterinary medicine. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.

The primary objective of this study is to assess the efficacy (based on cure rates [CR]) of the three combinations, i.e. albendazole-oxantel pamoate, pyrantel pamoate-oxantel pamoate and albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms in Laos. Secondary objectives include; i) a proof of concept, investigating the difference between the two triple combinations albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (based on CRs), ii) egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura and iii) tolerability of the 4 combinations.

Two stool samples will be collected from school-aged children (age 6-15) at baseline. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate treatment arms The medical history of the participating children will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Children will be interviewed before treatment for clinical symptoms and 3 and 24 hours after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples. All stool samples will be examined with duplicated Kato-Katz thick smears.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single-blind
Primary Purpose: Treatment
Official Title: Different Drug Combinations Against Hookworm Infection in School-aged Children in the Lao People's Democratic Republic, a Single Blind, Randomised Controlled Trial
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Albendazole triple combi
Albendazole (400 mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)
Drug: Albendazole
Albendazole (400 mg) from Janssen, donated by the World Health Organization

Drug: Pyrantel Pamoate
Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization

Drug: Oxantel Pamoate
Oxantel pamoate (20mg/kg) will be produced by the University of Basel

Experimental: Pyrantel pamoate double combi
Pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)
Drug: Pyrantel Pamoate
Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization

Drug: Oxantel Pamoate
Oxantel pamoate (20mg/kg) will be produced by the University of Basel

Experimental: Albendazole double combi
Albendazole (400 mg) + oxantel pamoate (20 mg/kg)
Drug: Albendazole
Albendazole (400 mg) from Janssen, donated by the World Health Organization

Drug: Oxantel Pamoate
Oxantel pamoate (20mg/kg) will be produced by the University of Basel

Experimental: Mebendazole triple combi
Mebendazole (500mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)
Drug: Pyrantel Pamoate
Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization

Drug: Oxantel Pamoate
Oxantel pamoate (20mg/kg) will be produced by the University of Basel

Drug: Mebendazole
Mebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization




Primary Outcome Measures :
  1. Cure rates of three drug combinations [ Time Frame: 14-21 days after treatment ]
    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.


Secondary Outcome Measures :
  1. Cure rates against hookworm of the two triple combinations [ Time Frame: 14-21 days after treatment ]
    To assess the CRs against hookworm of albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (proof of concept)

  2. Egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura [ Time Frame: 14-21 days after treatment ]
    Assessing the egg reduction rates (ERR) against hookworm and ERRs and cure rates (CR) against A. lumbricoides and T. trichiura

  3. Incidence of adverse events 3 and 24 hours after treatment [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278431


Locations
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Lao People's Democratic Republic
Nambak District Hospital
Luang Prabang, Lao People's Democratic Republic, 0604
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Keiser, Prof, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03278431    
Other Study ID Numbers: TRICOMBI01032017
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Mebendazole
Piperazine
Piperazine citrate
Pyrantel
Pyrantel Pamoate
Oxantel
Oxantel pamoate
DMP 777
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents