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NCT03664063 Clinical Trial

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

Trauma Clinical Trial

Official title:
A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03664063
Other study ID # ComboNTDs-PK
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2018
Est. completion date January 1, 2019

Study information
Verified date February 2019
Source Lihir Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date January 1, 2019
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
• Albendazole
Single dose of Albendazole weight based dosing - 400mg
• Ivermectin
Ivermectin weight based dosing - max 21mg
• Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg

Locations
Country Name City State
Papua New Guinea Lihir Medical Centre Londolovit New Ireland Province

Sponsors (1)
Lead Sponsor Collaborator
Lihir Medical Centre

Country where clinical trial is conducted

Papua New Guinea, 

Outcome
Type Measure Description Time frame Safety issue
Primary Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole 4 Days
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 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 Four days
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