Effect of Tebipenem on Normal Human Intestinal Microbiota

Phase 1 Completed 30 enrolled Spero Therapeutics IQVIA Pty Ltd · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The overall purpose of this study is to support the development of an oral formulation of TBPM-PI-HBr by assessing the potential ecological effects of tebipenem on the normal intestinal microbiota as compared to the effects of oral amoxicillin-clavulanate.

Timeline

Start: 2020-02-10
Primary completion: 2021-04-06
Completion: 2021-04-06

Publications

Sewunet T, Razavi M, Rosenborg S, Camporeale A, Nowak M, Melnick D, Gasink LB, Eckburg PB, Critchley IA, Nord CE, Giske CG. Effect of tebipenem pivoxil hydrobromide on the normal gut microbiota of a healthy adult population in Sweden: a randomised controlled trial. Lancet Microbe. 2024 Apr;5(4):e355-e365. doi: 10.1016/S2666-5247(23)00360-9. Epub 2024 Feb 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	500 mg	Oral
Subject	TBPM-PI-HBr	Small molecule	600 mg	Oral
Comparator	clavulanic acid	Small molecule	125 mg	Oral

Indications

No indication recorded.