Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Com⦠(NCT01067443) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisomeĀ® Combination, Miltefosine and AmBisomeĀ® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
Kenya, Sudan151 participantsStarted 2010-03
Plain-language summary
This study is to assess if shorter combinations of SSG plus single dose AmBisomeĀ®, Miltefosine plus single dose AmBisomeĀ® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
Who can participate
Age range7 Years ā 60 Years
SexALL
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Inclusion Criteria:
* Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
* Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
* 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.
* HIV negative status
Exclusion Criteria:
* Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
* Patients with a negative lymph node/bone marrow (or spleen) smears.
* Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI \</= 15, Children W/H\<70, presence of oedema)
* Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
* 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 patient's 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 female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
* Patients with haemoglobin \< 5gm/dl.
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