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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255567
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : March 22, 2016
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Brief 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.

Condition or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: Sodium Stibogluconate Drug: Paromomycin sulphate Drug: SSG and Paromomycin sulphate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear. [ Time Frame: 6 months post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255567

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Drugs for Neglected Diseases Identifier: NCT00255567     History of Changes
Other Study ID Numbers: DNDi-LEAP0104
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Drugs for Neglected Diseases:
Visceral Leishmaniasis
Additional relevant MeSH terms:
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Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antiplatyhelmintic Agents