Safety and efficacy of different albendazole-based treatment regimens to reduce microfilaraemia in subjects infected by Loa loa in an Gabo
- Conditions
- Eye infectionLoaLoa
- Registration Number
- PACTR201807197019027
- Lead Sponsor
- Ayola Akim Adegnika
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 42
Adult, male participants in the BuDiLoLo study
-L. loa microfilaria < 50,000 mf/mL
-Intention to remain residing in study area and comply with study procedures throughout 6 month follow-up period
-Signed written informed consent
-Patients treated with albendazole during the 4 previous weeks
-Known intolerance or allergy to any study drug
-Viral hepatitis (HBV, HCV) or other known active liver disease
-HIV or other known immunosuppressive condition
-History of epilepsy, encephalitis, meningitis or encephalopathy
-Any other acute or chronic medical condition, medication or psychosocial factor(s) deemed by the Investigator to put the potential participant at greater than acceptable risk or to significantly affect study outcomes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint will be the proportion of subjects with L. loa microfilarial levels <100 mf/mL ;the proportion of subjects without microscopically detectable microfilariae
- Secondary Outcome Measures
Name Time Method the occurrence of any grade 3 adverse event (AE) or serious adverse event (SAE) ;be assessed by the occurrence of all (grade 1-2) adverse events at least possibly related to study therapy;3.Proportion of subjects without peripheral microfilaraemia