Trial reportPLoS neglected tropical diseases2014
Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study.
Trial report in PLoS neglected tropical diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00876824 (A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul®), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
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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 Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Fixed-dose ivermectin for Mass Drug Administration: Is it time to leave the dose pole behind? Insights from an Individual Participant Data Meta-Analysis.PLoS neglected tropical diseases · 2025Pooled it
- Amphotericin B deoxycholate versus liposomal amphotericin B: effects on kidney function.The Cochrane database of systematic reviews · 2015Pooled it
- Effectiveness of Short-Course Meglumine Antimoniate (Glucantime®) for Treatment of Visceral Leishmaniasis: A 13-Year, Multistage, Non-Inferiority Study in Iran.The American journal of tropical medicine and hygiene · 2017Trial
- Leishmaniasis in Humans and Animals: A One Health Approach for Surveillance, Prevention and Control in a Changing World.Tropical medicine and infectious disease · 2024Article
- Review of Novel Oral Amphotericin B Formulations for the Treatment of Parasitic Infections.Pharmaceutics · 2022Review
- Limitations of current chemotherapy and future of nanoformulation-based AmB delivery for visceral leishmaniasis-An updated review.Frontiers in bioengineering and biotechnology · 2022Review
- Potential Anti-leishmanial Activity of a Semi-purified Fraction Isolated from the Leaves of Parthenium hysterophorus.Acta parasitologica · 2021Article
- Evaluation of La(XT), a novel lanthanide compound, in an OVX rat model of osteoporosis.Bone reports · 2021Article
- Organoboron Compounds: Effective Antibacterial and Antiparasitic Agents.Molecules (Basel, Switzerland) · 2021Review
- Assessing the Safety, Tolerability, Pharmacokinetics, and Biodistribution of Novel Oral Formulations of Amphotericin B following Single- and Multiple-Dose Administration to Beagle Dogs.Antimicrobial agents and chemotherapy · 2020Article
- A clioquinol-containing PluronicParasite (Paris, France) · 2020Article
- Lipid Systems for the Delivery of Amphotericin B in Antifungal Therapy.Pharmaceutics · 2020Review
- Effectiveness of Single-Dose Liposomal Amphotericin B in Visceral Leishmaniasis in Bihar.The American journal of tropical medicine and hygiene · 2019Observational
- Mushrooms: an emerging resource for therapeutic terpenoids.3 Biotech · 2019Review
- The Development of Oral Amphotericin B to Treat Systemic Fungal and Parasitic Infections: Has the Myth Been Finally Realized?Pharmaceutics · 2019Article
- Article
- Efficacy and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis in Children and Adolescents at a Tertiary Care Center in Bihar, India.The American journal of tropical medicine and hygiene · 2017Article
- Nanostructured delivery systems with improved leishmanicidal activity: a critical review.International journal of nanomedicine · 2017Review
- Successful Therapy of Murine Visceral Leishmaniasis with Astrakurkurone, a Triterpene Isolated from the Mushroom Astraeus hygrometricus, Involves the Induction of Protective Cell-Mediated Immunity and TLR9.Antimicrobial agents and chemotherapy · 2016Article
- Mucosal Vaccine Development Based on Liposome Technology.Journal of immunology research · 2016Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIndia is home to 60% of the total global visceral leishmaniasis (VL) population. Use of long-term oral (e.g. miltefosine) and parenteral drugs, considered the mainstay for treatment of VL, is now faced with increased resistance, decreased efficacy, low compliance and safety issues. The authors evaluated the efficacy and safety of an alternate treatment option, i.e. single infusion of preformed amphotericin B (AmB) lipid emulsion (ABLE) in comparison with that of liposomal formulation (LAmB).
methodsIn this multicentric, open-label study, 500 patients with VL were randomly assigned in a 3:1 ratio to receive 15 mg/kg single infusion of either ABLE (N = 376) or LAmB (N = 124). Initial cure (Day 30/45), clinical improvement (Day 30) and long term definitive cure (Day 180) were assessed.
findingsA total of 326 (86.7%) patients in the ABLE group and 122 (98.4%) patients in the LAmB group completed the study. Initial cure was achieved by 95.9% of patients in the ABLE group compared to 100% in the LAmB group (p = 0.028; 95% CI: -0.0663, -0.0150). Clinical improvement was comparable between treatments (ABLE: 98.9% vs. LAmB: 98.4%). Definitive cure was achieved in 85.9% with ABLE compared to 98.4% with LAmB. Infusion-related pyrexia (37.2% vs. 32.3%) and chills (18.4% vs. 18.5%) were comparable between ABLE and LAmB, respectively. Treatment-related serious adverse events were fewer in ABLE (0.3%) compared to LAmB (1.6%). Two deaths occurred in the ABLE group, of which one was probably related to the study drug. Nephrotoxicity and hepatotoxicity was not observed in either group.
conclusionsABLE 15 mg/kg single infusion had favorable efficacy and was well tolerated. Considering the demographic profile of the population in this region, a single dose treatment offers advantages in terms of compliance, cost and applicability.
trial registrationwww.clinicaltrials.gov NCT00876824.
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