Visceral Leishmaniasis Clinical Trial
Official title:
A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Verified date | October 2014 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
Status | Completed |
Enrollment | 667 |
Est. completion date | November 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age between 5-55 years (inclusive) of either gender. - Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate. - Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly. - Biochemical and haematological test values as follows: - Haemoglobin > 5.0g/100mL - White blood cell count > 1 x109/L - Platelet count > 50 x 109/L - AST, ALT and alkaline phosphatase < 3 times upper normal limit - Prothrombin time < 5 seconds above control - Serum creatinine levels within normal limits - Serum potassium levels within normal limits - HIV negative Exclusion Criteria: - A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study. - Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. - An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction. - Proteinuria (> 2+). - A history of allergy or hypersensitivity to aminoglycosides. - A history of major surgery within the last two weeks. - Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.] - Previous treatment for VL within two weeks of enrolment into the study. - Prior treatment failures with paromomycin or amphotericin B. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Rajendra Memorial Research Institute of Medical Sciences (ICMR) | Agam Kuan, Patna | Bihar |
India | Kalazar Research Centre | Brahmpura, Muzaffarpur | Bihar |
India | Kalazar Research Centre | Patna | Bihar |
India | Kala-azar Medical Research Centre | Rambagh Road Muzaffarpur | Bihar |
Lead Sponsor | Collaborator |
---|---|
PATH | World Health Organization |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens. | |||
Primary | (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates. | |||
Secondary | - Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL | |||
Secondary | - Comparison of initial cure rates for the two regimens | |||
Secondary | - Comparison of clinical improvement rates for the two regimens |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02839603 -
Asymptomatic Leishmania Infection in HIV Patients
|
||
Completed |
NCT00370825 -
Combination Chemotherapy for the Treatment of Indian Kala-Azar
|
Phase 2 | |
Recruiting |
NCT05426577 -
Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
|
||
Completed |
NCT01069198 -
A Community Trial for Visceral Leishmaniasis (VL)
|
N/A | |
Completed |
NCT01032187 -
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
|
Phase 4 | |
Completed |
NCT00371995 -
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
|
Phase 2 | |
Completed |
NCT00604955 -
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
|
Phase 4 | |
Completed |
NCT00342823 -
Immunogenetics of Visceral Leishmaniasis
|
N/A | |
Completed |
NCT04003532 -
LAMP Assay for the Diagnosis of Visceral Leishmaniasis
|
||
Terminated |
NCT01980199 -
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
|
Phase 2 | |
Completed |
NCT00255567 -
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
|
Phase 3 | |
Not yet recruiting |
NCT06118749 -
Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
|
||
Recruiting |
NCT04342715 -
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
|
||
Completed |
NCT02431143 -
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
|
Phase 2 | |
Completed |
NCT01122771 -
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
|
Phase 3 | |
Completed |
NCT03636659 -
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
|
Phase 1 | |
Not yet recruiting |
NCT01566552 -
Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
|
Phase 4 | |
Completed |
NCT00696969 -
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
|
Phase 3 | |
Completed |
NCT00318721 -
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
|
N/A | |
Completed |
NCT02011958 -
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
|
Phase 3 |