Status:
COMPLETED
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
4-60 years
Phase:
PHASE3
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.
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 tha...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- Patients who have received any anti-leishmanial drug in the last 6 months.
- Patients with a negative splenic / lymph node / bone marrow smears.
- Patients with a clinical contraindication to splenic/lymph node/ bone marrow aspirates.
- Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)
- Patients with previous hypersensitivity reaction to SSG or aminoglycosides.
- 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.
- Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
- Patients with previous history of cardiac arrhythmia or an abnormal ECG
- Patients who are pregnant or lactating.
- Patients with haemoglobin \< 5gm/dl.
- Patients with WBC \< 1 x 10³/mm³.
- Patients with platelets \< 40,000/mm³.
- Patients with liver function tests more than three times the normal range
- Patients with serum creatinine outside the normal range for age and gender
- Patients with pre-existing clinical hearing loss.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1142 Patients enrolled
Trial Details
Trial ID
NCT00255567
Start Date
November 1 2004
End Date
January 1 2010
Last Update
March 22 2016
Active Locations (5)
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1
Arba Minch Hospital
Arba Minch, Ethiopia
2
Gondar hospital
Gonder, Ethiopia
3
KEMRI
Nairobi, Kenya
4
Kassab Hospital
Kassāb, Sudan