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Observational Study
. 2025 Jul 15;25(1):920.
doi: 10.1186/s12879-025-11319-1.

Experience of research nurses with oral encochleated amphotericin B for treatment of cryptococcal meningitis in a resource-limited setting

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Observational Study

Experience of research nurses with oral encochleated amphotericin B for treatment of cryptococcal meningitis in a resource-limited setting

Cynthia Ahimbisibwe et al. BMC Infect Dis. .

Abstract

Background: Besides the commonly used intravenous formulations of amphotericin B, an oral nanocrystal amphotericin B (MAT2203) formulation is being evaluated for efficacy to treat invasive fungal infections. This new experimental oral formulation has not been used before.

Methods: Herein, we describe our experiences with using oral amphotericin B for management of patients with HIV-associated cryptococcal meningitis in Uganda from a research nurse perspective.

Results: We found oral amphotericin B a better alternative to intravenous amphotericin B deoxycholate due to less toxicity, mostly limited to gastrointestinal-related toxicities only. We clinically observed no drug reactions like rigors, phlebitis, and less vomiting among patients on oral amphotericin B as compared to those on intravenous amphotericin B deoxycholate. Subjectively, meningitis symptoms of patients on oral amphotericin B seemed to overall clinically improve more rapidly compared to those receiving intravenous amphotericin B deoxycholate. Few adverse events were observed. A novel challenge with oral amphotericin was difficulty in monitoring adherence for the night doses in the absence of the healthcare providers.

Conclusions: Oral amphotericin B was generally safe and well tolerated. However, it requires some training for the nurse, patient and care takers for better administration, adherence and treatment outcomes.

Trial registration: This was observational sub-study that was nested under the EnACT trial. The EnACT trial was registered prospectively. ClincalTrials.gov: NCT04031833; Registration date: July 24, 2019; Last verified: March 31, 2023.

Keywords: Amphotericin B; Clinical research; Cryptococcal meningitis; Research nurse; Uganda.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This was an observational sub-study that was nested under the ENACT trial which was approved by the Mulago Hospital Research Ethics Committee (1195); University of Minnesota Ethics Committee (STUDY00000139); Uganda National Council of Science & Technology (HS 2351); Uganda National Drug Authority (854/NDA/DPS/08/2018); United States Food and Drug Administration (IND 72807). All participants were adults aged 18 years and above. Participants provided informed consent for study participation in the ENACT trial and all its sub-studies including storage of samples for future use. The study was carried out in compliance with the international good clinical practice guidelines and the Helsinki Declaration. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

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