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

Visceral Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255567
• Other study ID #: DNDi-LEAP0104
• 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

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

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