Trial reportTrials2011
Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial.
Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01067443 (A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa), which is not on this map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa
Who cites it
25 citing papers in PubMed, 71 citations in OpenAlex.
- Population pharmacokinetics of a combination of miltefosine and paromomycin in Eastern African children and adults with visceral leishmaniasis.The Journal of antimicrobial chemotherapy · 2023Trial
- Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa: A Randomized, Controlled, Multicountry Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial.PLoS neglected tropical diseases · 2016Trial
- Validation and Clinical Evaluation of a Novel Method To Measure Miltefosine in Leishmaniasis Patients Using Dried Blood Spot Sample Collection.Antimicrobial agents and chemotherapy · 2016Trial
- Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups.Trials · 2015Trial
- Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial.PLoS neglected tropical diseases · 2014Trial
- Triangular test design to evaluate tinidazole in the prevention of Plasmodium vivax relapse.Malaria journal · 2013Trial
- Pentalinonsterol at the Host-Parasite Interface: Antileishmanial Activity, Host Immunomodulation, and Unresolved Mechanisms.Acta parasitologica · 2026Review
- Free Radical Production Induced by Nitroimidazole Compounds Lead to Cell Death inMolecules (Basel, Switzerland) · 2024Article
- Epidemiology, clinical characteristics, and treatment outcomes of leishmaniasis in Qatar: A retrospective study.Qatar medical journal · 2024Article
- Miltefosine and Nifuratel Combination: A Promising Therapy for the Treatment ofInternational journal of molecular sciences · 2023Article
- Systems biology of autophagy in leishmanial infection and its diverse role in precision medicine.Frontiers in molecular biosciences · 2023Review
- Omics Approaches in Drug Development against Leishmaniasis: Current Scenario and Future Prospects.Pathogens (Basel, Switzerland) · 2022Review
- Leishmanicidal effects of amphotericin B in combination with selenium loaded on niosome againstJournal of parasitic diseases : official organ of the Indian Society for Parasitology · 2019Article
- Drug resistance and treatment failure in leishmaniasis: A 21st century challenge.PLoS neglected tropical diseases · 2017Review
- Nanotized Curcumin and Miltefosine, a Potential Combination for Treatment of Experimental Visceral Leishmaniasis.Antimicrobial agents and chemotherapy · 2017Article
- Recent developments and future prospects in the treatment of visceral leishmaniasis.Therapeutic advances in infectious disease · 2016Review
- Host-mediated Leishmania donovani treatment using AR-12 encapsulated in acetalated dextran microparticles.International journal of pharmaceutics · 2016Article
- An update on pharmacotherapy for leishmaniasis.Expert opinion on pharmacotherapy · 2015Review
- Combination therapy with tamoxifen and amphotericin B in experimental cutaneous leishmaniasis.Antimicrobial agents and chemotherapy · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 5 countries.
Funding
Abstract
backgroundTreatment options for visceral leishmaniasis (VL) in East Africa are far from satisfactory due to cost, toxicity, prolonged treatment duration or emergence of parasite resistance. Hence there is a need to explore alternative treatment protocols such as miltefosine alone or in combinations including miltefosine, sodium stibogluconate (SSG) or liposomal amphotericin B. The aim of this trial is to identify regimen(s) which are sufficiently promising for future trials in East Africa. METHODS/
designA phase II randomized, parallel arm, open-labelled trial is being conducted to assess the efficacy of each of the three regimens: liposomal amphotericin B with SSG, Liposomal amphotericin B with miltefosine and miltefosine alone. The primary endpoint is cure at day 28 with secondary endpoint at day 210 (6 months). Initial cure is a single composite measure based on parasitologic evaluation (bone marrow, spleen or lymph node aspirate) and clinical assessment. Repeated interim analyses have been planned after recruitment of 15 patients in each arm with a maximum sample size of 63 for each. These will follow group-sequential methods (the triangular test) to identify when a regimen is inadequate (<75% efficacy) or adequate (>90% efficacy). We describe a method to ensure consistency of the sequential analysis of day 28 cure with the non-sequential analysis of day 210 cure. DISCUSSION: A regimen with adequate efficacy would be a candidate for treatment of VL with reasonable costs. The design allows repeated testing throughout the trial recruitment period while maintaining good statistical properties (Type I & II error rates) and reducing the expected sample sizes.
trial registrationClinicalTrials.gov: NCT01067443.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.