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Phase IIb trial of DUOFAG for bacterial infections in complicated skin wounds

2025-522752-45-00Phase 3Authorised

Sponsor
MB Pharma
Start
Feb 2026
Modality
Live Biotherapeutic Products → Microbiome Therapeutics
Countries
1
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Overview

Phase 3, randomised, double-blind trial in Wound infection (WI), surgical site infection (SSI), secondarily infected traumatic lesion (SITL) and 2 more comparing DUOFAG arm with Placebo arm (2 arms). Primary endpoints: Safety (serious adverse reactions/events during IMP administration phase), Efficiency (1) presence of S. aureus and/or P. aeruginosa colonies and 1 more. Planned start Feb 2026; status: authorised.

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Drugs

DUOFAG
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Conditions

Wound infection (WI)surgical site infection (SSI)secondarily infected traumatic lesion (SITL)Staphylococcus aureus infectionPseudomonal infection

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