MedTrace Logo

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

NCT03664063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-02-28

No results posted yet for this study

Summary

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.

Conditions

  • Lymphatic Filariasis
  • Yaws
  • Trauma

Interventions

DRUG

Azithromycin

Treatment with Azithromycin single dose - weight based dosing max 2gm

DRUG

Albendazole

Single dose of Albendazole weight based dosing \- 400mg

DRUG

Ivermectin

Ivermectin weight based dosing - max 21mg

DRUG

Diethylcarbamazine

Diethylcarbamazine weight based dosing - max 500mg

Sponsors & Collaborators

  • Lihir Medical Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-10-01
Completion
2019-01-01

Countries

  • Papua New Guinea

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03664063 on ClinicalTrials.gov