NCT03278431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

September 6, 2017

Last Update Submit

May 7, 2018

Conditions

Hookworm Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cure rates against hookworm of the two triple combinations

    14-21 days after treatment

  • Egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura

    14-21 days after treatment

  • Incidence of adverse events 3 and 24 hours after treatment

    3 and 24 hours after treatment

Study Arms (4)

Albendazole triple combi

ACTIVE COMPARATOR

Albendazole (400 mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)

Drug: AlbendazoleDrug: Pyrantel PamoateDrug: Oxantel Pamoate

Pyrantel pamoate double combi

EXPERIMENTAL

Pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)

Drug: Pyrantel PamoateDrug: Oxantel Pamoate

Albendazole double combi

EXPERIMENTAL

Albendazole (400 mg) + oxantel pamoate (20 mg/kg)

Drug: AlbendazoleDrug: Oxantel Pamoate

Mebendazole triple combi

EXPERIMENTAL

Mebendazole (500mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg)

Drug: Pyrantel PamoateDrug: Oxantel PamoateDrug: Mebendazole

Interventions

AlbendazoleDRUG

Albendazole (400 mg) from Janssen, donated by the World Health Organization

Albendazole double combiAlbendazole triple combi
Pyrantel PamoateDRUG

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

Albendazole triple combiMebendazole triple combiPyrantel pamoate double combi
Oxantel PamoateDRUG

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

Albendazole double combiAlbendazole triple combiMebendazole triple combiPyrantel pamoate double combi
MebendazoleDRUG

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

Mebendazole triple combi

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nambak District Hospital

Luang Prabang, 0604, Laos

Location

Related Publications (1)

  • Moser W, Sayasone S, Xayavong S, Bounheuang B, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and tolerability of triple drug therapy with albendazole, pyrantel pamoate, and oxantel pamoate compared with albendazole plus oxantel pamoate, pyrantel pamoate plus oxantel pamoate, and mebendazole plus pyrantel pamoate and oxantel pamoate against hookworm infections in school-aged children in Laos: a randomised, single-blind trial. Lancet Infect Dis. 2018 Jul;18(7):729-737. doi: 10.1016/S1473-3099(18)30220-2. Epub 2018 Apr 16.

    PMID: 29673735DERIVED

MeSH Terms

Conditions

Hookworm Infections

Interventions

AlbendazolePyrantel Pamoateoxantel pamoateMebendazole

Condition Hierarchy (Ancestors)

Strongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrantelThiophenesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

September 27, 2017

Primary Completion

November 17, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)