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

This study has been completed.
Sponsor:
Information provided by:
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT00255567
First received: November 16, 2005
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Sodium Stibogluconate
Drug: Paromomycin sulphate
Drug: SSG and Paromomycin sulphate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear. [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]

Enrollment: 1142
Study Start Date: November 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sodium Stibogluconate (30 days)
Drug: Sodium Stibogluconate
Sodium Stibogluconate 20mg/kg/day for 30 days
Experimental: 2
Paromomycin Sulphate (21 days)
Drug: Paromomycin sulphate
Paromomycin sulphate
Experimental: 3
Sodium Stibogluconate + Paromomycin Sulphate (17 days)
Drug: SSG and Paromomycin sulphate
SSG and Paromomycin Sulphate 17 days

Detailed 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.

  Eligibility

Ages Eligible for Study:   4 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
  2. Patients aged between 4 and 60 years (inclusive) who are able to comply with the protocol. It is justified to include children because they represent more than 50% of VL cases.
  3. Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (spleen, lymph node or bone marrow) on microscopy.

Exclusion Criteria:

  1. Patients who have received any anti-leishmanial drug in the last 6 months.
  2. Patients with a negative splenic / lymph node / bone marrow smears.
  3. Patients with a clinical contraindication to splenic/lymph node/ bone marrow aspirates.
  4. Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)
  5. Patients with previous hypersensitivity reaction to SSG or aminoglycosides.
  6. Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patients response to study medication.
  7. Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
  8. Patients with previous history of cardiac arrhythmia or an abnormal ECG
  9. Patients who are pregnant or lactating.
  10. Patients with haemoglobin < 5gm/dl.
  11. Patients with WBC < 1 x 10³/mm³.
  12. Patients with platelets < 40,000/mm³.
  13. Patients with liver function tests more than three times the normal range
  14. Patients with serum creatinine outside the normal range for age and gender
  15. Patients with pre-existing clinical hearing loss.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255567

Locations
Ethiopia
Arba Minch Hospital
Arba Minch, Ethiopia
Gondar hospital
Gondar, Ethiopia
Kenya
KEMRI
Nairobi, Kenya
Sudan
Kassab Hospital
Kassab, Sudan
Uganda
Amudat Hospital
Amudat, Nakipiripirit district, Uganda
Sponsors and Collaborators
Drugs for Neglected Diseases
Investigators
Study Director: Manica Balasegaram Drugs for Neglected Diseases
  More Information

No publications provided by Drugs for Neglected Diseases

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sally Ellis, Clinical Project Coordinator, DNDi
ClinicalTrials.gov Identifier: NCT00255567     History of Changes
Other Study ID Numbers: DNDi-LEAP0104
Study First Received: November 16, 2005
Last Updated: February 10, 2010
Health Authority: Kenya: KEMRI/National Ethical Committee
Ethiopia: Natioanl Ethics committee and Addis Ababa Science and Technology committee
Sudan: Institute of endemic diseases ethics committee
Uganda: Makarere University Ethics committee

Keywords provided by Drugs for Neglected Diseases:
Visceral Leishmaniasis
Combination

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Antimony Sodium Gluconate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on September 18, 2014