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

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.

Timeline

Start

2018-09-01

Primary completion

2018-10-01

Completion

2019-01-01

Outcome

Met primary endpoint

paper The GMR of Cmax, AUC0-t, and AUC0-∞ for IVM, DEC, ALB-SOX, and AZI were within the range of 80-125% PMID 32818264 ↗

Publications

• Alshehri A, Chhonker YS, Bala V, Edi C, Bjerum CM, Koudou BG, John LN, Mitja O, Marks M, King CL, Murry DJ. Population pharmacokinetic model of ivermectin in mass drug administration against lymphatic filariasis. PLoS Negl Trop Dis. 2023 Jun 1;17(6):e0011319. doi: 10.1371/journal.pntd.0011319. eCollection 2023 Jun.
• John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print.

Drugs

Indications