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

Phase 2

Completed

• Conditions: Trauma; Lymphatic Filariasis; Yaws
• Interventions: Drug: Azithromycin; Drug: Albendazole; Drug: Ivermectin; Drug: Diethylcarbamazine

• Registration Number: NCT03664063
• Lead Sponsor: Lihir Medical Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Primary Completion: 2018-10-01
• Study Completion: 2019-01-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adult aged 18-65
• Able to give informed consent

Exclusion Criteria

• Known chronic illness
• Hb <7 at baseline
• Liver function or Creatinine * 1.5 Upper Limit of Normal
• Urinary tract infection at baseline
• Pregnancy (female participants only)
• Routine medications which interact with study drugs
• Lactose/Gluten intolerance
• Permanent disability impeding study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin for Yaws	Azithromycin	Patients will receive standard treatment for yaws alone
IDA for Lymphatic Filariasis	Diethylcarbamazine	Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone
IDA for Lymphatic Filariasis	Albendazole	Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone
IDA for Lymphatic Filariasis	Ivermectin	Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone
Combination Therapy of Azithromycin for Yaws and IDA for LF	Azithromycin	Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Combination Therapy of Azithromycin for Yaws and IDA for LF	Albendazole	Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Combination Therapy of Azithromycin for Yaws and IDA for LF	Diethylcarbamazine	Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Combination Therapy of Azithromycin for Yaws and IDA for LF	Ivermectin	Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.

Primary Outcome Measures

Name	Time	Method
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole	4 Days	Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Four days	Patients will undergo regular monitoring for the duration of the study - adverse events will be graded from 1 to 4 in line with the CTCAE v4.0

Trial Locations

Locations (1)

Lihir Medical Centre; 🇵🇬 Londolovit, New Ireland Province, Papua New Guinea