Visceral Leishmaniasis Clinical Trial
Official title:
A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present
themselves in remote areas and need to be treated in relative resource poor settings. It is
for this reason that standardised treatment with proven efficacy is much needed. A shorter
course of treatment is not only advantageous for the patient but also reduces the overall
case load in the clinics thus reducing the risk of disease outbreaks in already
immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG
would decrease the treatment duration substantially. An additional added value of
combination therapy is that it is likely to reduce the chances of development of parasite
resistance against the individual drugs.
Leishmaniasis experts in the three countries are in agreement that there are potential
benefits of the combination treatment of SSG and PM and that its efficacy should be
evaluated with the view to introduce this protocol if proven efficacious and safe. There is
ample circumstantial evidence of the use of this combination therapy and its efficacy and
tolerability as a standardized protocol. This can only be confirmed through a randomised
controlled study with 6 months follow up.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | |
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 |
NCT00216346 -
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
|
Phase 3 | |
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 |