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Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

NCT03676140 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2019-02-28

No results posted yet for this study

Summary

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.

Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.

Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

Conditions

  • Trachoma
  • Yaws
  • Lymphatic Filariases
  • Scabies
  • Strongyloidiasis

Interventions

DRUG

Albendazole on Day 1

Albendazole 400 mg oral tablet Single Dose Treatment on D1

DRUG

Ivermectin on Day 1

Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1

DRUG

Diethylcarbamazine on day 1

Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1

DRUG

Azithromycin on Day 1

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1

DRUG

Azithromycin on Day 8

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Lihir Medical Centre

    lead OTHER

Principal Investigators

  • Lucy John, MD · National Department of Health of Papua New Guinea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2018-12-15
Completion
2019-01-01

Countries

  • Papua New Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676140 on ClinicalTrials.gov