drugset / Trial / NCT03676140
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
Phase 3
Completed
20000 enrolled
Lihir Medical Centre
London School of Hygiene and Tropical Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2018-12-15
- Completion
- 2019-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 30 mg/kg | Oral |
| Background | Albendazole | Small molecule | 400 mg | Oral |
| Background | Diethylcarbamazine | Small molecule | 6 mg/kg | Oral |
| Background | Ivermectin | Small molecule | 200 ug/kg | Oral |