NCT03676140

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

A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20,000 (actual)
• Sponsor: Lihir Medical Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin \[IVE\] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea. Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a \>95% reduction in prevalence sustained for nine months. Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated. Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.

Conditions

• Trachoma
• Yaws
• Lymphatic Filariases
• Scabies
• Strongyloidiasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-12-15
• Completion: 2019-01-01
• First posted: 2018-09-18
• Last updated: 2019-02-28

Locations

1 site across 1 country: Papua New Guinea