Clinical Trials Logo
  1. Home
  2. Visceral Leishmaniasis
  3. NCT00255567

Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00255567
Study type Interventional
Source Drugs for Neglected Diseases
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date January 2010
View Details
See also
  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 NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
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 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