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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Treatments: Antimony Sodium Gluconate; Paromomycin

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.