Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371995
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2006-09-05
Brief Title:
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
Sponsor:
Banaras Hindu University
Organization:
Banaras Hindu University
Study Overview
Official Title:
The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Miltefosine and liposomal amphotericin B AmBisome are approved drugs for visceral leishmaniasis In this study both drugs will be given in a sequential manner AmBisome will be given on day 1 followed by Miltefosine for 14 days Final Cure will be evaluated at six months
Detailed Description:
Methodology Multicenter trial eligible patients will be treated with Liposomal amphotericin B 5 mgkg on day 1 and then with miltefosine capsules for 14 days days 2-15
At two weeks after the end of treatment the initial cure clinical and parasitological cure and the clinical response will be determined If initial cure is observed a patient will be evaluated after a 6 months after end of treatment follow up period for final clinical cure
Number of patients planned Total number of patients planned 150 patients at both centers combined 75 pediatric 2-11 years 75 adult 12-65 years
Lack of suitability for the trial
Post Kala-azar Dermal Leishmaniasis PKDL
Concomitant treatment with other anti-leishmanial drugs
Any condition which compromises ability to comply with the study procedures
Administrative reasons
Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1 Dosage 5 mgkg
Miltefosine administered orally 50 mg capsules for 14 days on days 2-15
Dosage
1 weighing 25 kg 100 mg miltefosine daily as one capsule 50 mg in the morning and one capsule in the evening after meals for 14 days
2 weighing 25 kg 50 mg miltefosine daily as one capsule 50 mg in the morning after meals for 14 days Parameter for evaluation
Final cure rate initial parasite cure and clinical assessment at six month EOT
Initial parasitological cure rate based on splenic aspirates or Bone marrow aspirate
Clinical response at end of treatment clinical assessment
Adverse events
Statistical methods
Calculation of cure rate with 95 and 90 lower confidence limit according to Clopper Pearson
Calculation of overall incidence of adverse events
At two weeks after the end of treatment the initial cure clinical and parasitological cure and the clinical response will be determined If initial cure is observed a patient will be evaluated after a 6 months after end of treatment follow up period for final clinical cure
Number of patients planned Total number of patients planned 150 patients at both centers combined 75 pediatric 2-11 years 75 adult 12-65 years
Lack of suitability for the trial
Post Kala-azar Dermal Leishmaniasis PKDL
Concomitant treatment with other anti-leishmanial drugs
Any condition which compromises ability to comply with the study procedures
Administrative reasons
Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1 Dosage 5 mgkg
Miltefosine administered orally 50 mg capsules for 14 days on days 2-15
Dosage
1 weighing 25 kg 100 mg miltefosine daily as one capsule 50 mg in the morning and one capsule in the evening after meals for 14 days
2 weighing 25 kg 50 mg miltefosine daily as one capsule 50 mg in the morning after meals for 14 days Parameter for evaluation
Final cure rate initial parasite cure and clinical assessment at six month EOT
Initial parasitological cure rate based on splenic aspirates or Bone marrow aspirate
Clinical response at end of treatment clinical assessment
Adverse events
Statistical methods
Calculation of cure rate with 95 and 90 lower confidence limit according to Clopper Pearson
Calculation of overall incidence of adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None