The pharmacology of azithromycin in severe malaria bacterial co-infection in African childre

Phase 1

Completed

• Conditions: Severe Malaria; Infections and Infestations

• Registration Number: ISRCTN49726849
• Lead Sponsor: Imperial College, London

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37519413/ (added 31/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-27
• Study Completion: 2022-12-30
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Children aged 6 months to 12 years at admission to hospital with Plasmodium falciparum malaria (on either blood film or ParacheckTM rapid diagnostic test)
2. Axillary temperature >380C or <360C
3. ‘Teule’ severity criteria: any one of the following: prostration; respiratory distress; severe anaemia (haemoglobin<5g/dL) or HIV infection
4. Parents willing/able to provide consent

Exclusion Criteria

1. Major contraindications to azithromycin, eg strong existing clinical diagnosis of QT-prolongation
2. Concomitant use of interacting drugs: drugs that may cause QT-prolongation or drugs that may cause a pharmacokinetic interaction with azithromycin, like strong CYP3A/P-GP inducers and concomitantly administered antacids

Study & Design

• Study Type: Interventional
• Study Design: Not specified