Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
|ClinicalTrials.gov Identifier: NCT01566552|
Recruitment Status : Unknown
Verified March 2012 by Shyam Sundar, Banaras Hindu University.
Recruitment status was: Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Visceral Leishmaniasis||Drug: AMBISOME||Phase 4|
Hide Detailed Description
To evaluate the operational feasibility of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome® single dose of 10 mg/kg, when administrated at the Primary Health Centers (PHC) setting with regard to feasibility and safety .
To determine efficacy of the treatment scheme when delivered by district hospitals and PHC facilities
Three districts, Saran, Simastipur and Muzaffarpur in the VL endemic state of Bihar in India will be selected for the study. Initially, 300 eligible patients will be diagnosed and treated at hospital level with liposomal amphotericin B, using a single dose of 10 mg/kg. If no significant feasibility or safety issues are identified in this group of patients, 1000 additional subjects will be diagnosed and treated at the PHC level. Feasibility will be determined by the proportion of patients attending the PHCs treated with single dose AmBisome and the proportion of patients that need to be referred to the district hospitals for management of adverse events. The initial cure rate will be determined at day 30, after end of treatment (EOT). If initial cure is observed, the patient will be followed up and evaluated 6 months after the end of treatment for final clinical cure.
Study medication, dose and mode of administration Liposomal Amphotericin B (Gilead Sciences, Foster City, CA, USA) is formulated as a lyophilized powder which will be reconstituted in 10 ml of distilled water as a solution and the total dose will be then diluted in three times the volume of 5% dextrose solution.
Total infusion will be done in 2 hours.
Before infusion of AmBisome®, each patient will be given Paracetamol (Adult: 500 mg; Children below 12 years 10 mg/kg) and Chlorpheniramine (Adult: 4mg; Children below 12 years 1-2mg)
Parameters for evaluation Laboratory parameters for safety Adverse event
- 85% of VL patients attending the PHCs are treated with the single dose AmBisome scheme.
- 3% of patients treated with single dose AmBisome are referred to district hospitals for AEs management .
- 95% of patients treated with single dose AmBisome are cure at 6 months after EOT.
Endpoints (Efficacy) Initial Cure: Defined as remission of fever, any decrease in spleen size compared with baseline, hemoglobin is increased by at least 10% compared to baseline or to at least 10g/dl, and improvement in other clinical signs and symptoms on day 30.
Final Cure: Defined on the fulfillment of following criteria at 6 months after EOT: No relapse after initial cure, absence of fever and no increase in spleen size compared with day 30 and hemoglobin is increased by at least10% compared to day 30 or to at least 10g/dl.
Statistical methods Efficacy analysis: Calculation of cure rate with 95% and 90% lower confidence limit according to the Clopper Pearson method.
Safety analysis: Calculation of overall incidence of adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
|SINGLE DOSE AMBISOME||
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Name: LIPOSOMAL AMPHOTERECIN B
- CLINICAL CURE [ Time Frame: 24 MONTHS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566552
|Contact: ANUP SINGH, M.D.||09198332093||DRANUPBHU@GMAIL.COM|
|Contact: JAYA CHAKRAVARTY, M.D.||915422369632||TAPADAR@GMAIL.COM|
|Kala Azar Medical Research Center||Not yet recruiting|
|Muzaffarpur, Bihar, India, 842001|
|Contact: DEEPAK VERMA, MBBS 916212287570 KMARCMFP@HOTMAIL.COM|
|Principal Investigator:||SHYAM SUNDAR, M.D.||Banaras Hindu University|