Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
This study is not yet open for participant recruitment.
Verified March 2012 by Banaras Hindu University
Sponsor:
Banaras Hindu University
Collaborator:
Rajendra Memorial Research Institute of Medical Sciences
Information provided by (Responsible Party):
Shyam Sundar, Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT01566552
First received: March 27, 2012
Last updated: February 4, 2013
Last verified: March 2012
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Purpose
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
| Condition | Intervention | Phase |
|---|---|---|
|
Visceral Leishmaniasis |
Drug: AMBISOME |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India. |
Resource links provided by NLM:
Further study details as provided by Banaras Hindu University:
Primary Outcome Measures:
- CLINICAL CURE [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1300 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| SINGLE DOSE AMBISOME |
Drug: AMBISOME
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Name: LIPOSOMAL AMPHOTERECIN B
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients ≥ 5 years of age
- History of fever for more than 2 weeks
- Splenomegaly
- rK 39 rapid test positive
Biochemical and hematological test values as follows:
- Hemoglobin ≥ 5 g/dl
- White blood cell count ≥1.0 x 109/L
- AST, ALT ≤ 3 times the upper limit of normal
- Serum creatinine level within normal limit
- Written informed consent from the patient/ or parent or guardian if under 18 years old.
Exclusion Criteria:
- A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.
- Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- A history of allergy or hypersensitivity to Amphotericin B
- Previous treatment for VL
- Prior treatment failure with Amphotericin B
- Post Kala-azar Dermal Leishmaniasis (PKDL
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566552
Contacts
| Contact: ANUP SINGH, M.D. | 09198332093 | DRANUPBHU@GMAIL.COM |
| Contact: JAYA CHAKRAVARTY, M.D. | 915422369632 | TAPADAR@GMAIL.COM |
Locations
| India | |
| Kala Azar Medical Research Center | Not yet recruiting |
| Muzaffarpur, Bihar, India, 842001 | |
| Contact: DEEPAK VERMA, MBBS 916212287570 KMARCMFP@HOTMAIL.COM | |
Sponsors and Collaborators
Banaras Hindu University
Rajendra Memorial Research Institute of Medical Sciences
Investigators
| Principal Investigator: | SHYAM SUNDAR, M.D. | Banaras Hindu University |
More Information
No publications provided
| Responsible Party: | Shyam Sundar, PROFESSOR, Banaras Hindu University |
| ClinicalTrials.gov Identifier: | NCT01566552 History of Changes |
| Other Study ID Numbers: | BHU001/2012 |
| Study First Received: | March 27, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | India: Indian Council of Medical Research India: Drugs Controller General of India |
Keywords provided by Banaras Hindu University:
|
AMBISOME VISCERAL LEISHMANIASIS SINGLE DOSE |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Amphotericin B |
Liposomal amphotericin B Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013