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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255567
Other study ID # DNDi-LEAP0104
Secondary ID
Status Completed
Phase Phase 3
First received November 16, 2005
Last updated March 21, 2016
Start date November 2004
Est. completion date January 2010

Study information

Verified date March 2016
Source Drugs for Neglected Diseases
Contact n/a
Is FDA regulated No
Health authority Kenya: KEMRI/National Ethical CommitteeEthiopia: Natioanl Ethics committee and Addis Ababa Science and Technology committeeSudan: Institute of endemic diseases ethics committeeUganda: Makarere University Ethics committee
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1142
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 60 Years
Eligibility 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.

Study Design

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


Intervention

Drug:
Sodium Stibogluconate
Sodium Stibogluconate 20mg/kg/day for 30 days
Paromomycin sulphate
Paromomycin sulphate
SSG and Paromomycin sulphate
SSG and Paromomycin Sulphate 17 days

Locations

Country Name City State
Ethiopia Arba Minch Hospital Arba Minch
Ethiopia Gondar hospital Gondar
Kenya KEMRI Nairobi
Sudan Kassab Hospital Kassab
Uganda Amudat Hospital Amudat Nakipiripirit district

Sponsors (1)

Lead Sponsor Collaborator
Drugs for Neglected Diseases

Countries where clinical trial is conducted

Ethiopia,  Kenya,  Sudan,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear. 6 months post treatment No
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