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

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lihir Medical Centre
• Collaborator: London School of Hygiene and Tropical Medicine
• Treatments: Albendazole; Azithromycin; Diethylcarbamazine; Ivermectin

Criteria

Inclusion Criteria:

• Able to give consent

Exclusion Criteria:

• Unable to give consent.

• Less than 5 years of age (not eligible for ivermectin)**

• Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)

• Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**

• History of allergies to the drugs being studied

• Residents who cannot swallow tablets

Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations