✓ Translated by DotMD AI Clinical Council Source: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #36164254 ↗

Phase III Randomized Trial: Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa

Original Paper Title: “Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa: A Randomized, Controlled, Multicountry Trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • PM/MF and SSG/PM efficacies were similar, and adverse drug reactions were as expected given the drugs safety profiles. With 1 less injection each day, reduced treatment duration, and no risk of SSG-associated life-threatening cardiotoxicity, PM/MF is a more patient-friendly alternative for children and adults with primary visceral leishma.
  • Study Design & Sample: Phase III Randomized Trial published in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (2023), this phase iii randomized trial evaluating human clinical outcomes investigated: This study aimed to determine whether paromomycin plus miltefosine (PM/MF) is noninferior to sodium stibogluconate plus paromomycin (SSG/PM) for treatment of primary visceral leishmaniasis in eastern Africa. Key clinical takeaway: PM/MF and SSG/PM efficacies were similar, and adverse drug reactions were as expected given the drugs safety profiles. With 1 less injection each day, reduced treatment duration, and no risk of SSG-associated life-threatening cardiotoxicity,...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023-02-08; Phase III Randomized Trial; Rigor 82/100): PM/MF and SSG/PM efficacies were similar, and adverse drug reactions were as expected given the drugs safety profiles. With 1 less injection each day, reduced treatment duration, and no risk of SSG-associated life-threatening cardiotoxicity, PM/MF is a more patient-friendly alternative for children and adults with primary visceral leishma.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: paromomycin-sulfate → Rx: miltefosine → Rx: bio-combination-28-schuessler-salts → Rx: calcium-gluconate → Condition: leishmaniasis → Condition: bipolar-disorder-in-full-remission-most-recent-episode-depressed → Condition: bipolar-disorder-in-partial-remission-most-recent-episode-mixed →
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