Hypermicrofilaremic loiasis Infections and Infestations
Conditions
Interventions
A 30-day treatment of albendazole will be given in three experimental groups: a control group ( 8000 mf/ml) who will receive 400 and 800 mg albendazole. A histamine Type-2 receptor antagonist (H2 bloc
10 mg/kg) will also be given for 7 first days of the treatment. Blood samples for parasitological diagnosis (direct examination and leukoconcentration) will be performed on Day (D0) before the initiat
Sponsors
Université des Sciences de la Santé
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years with a weight below 90.1 kg 2. Positive for hypermicrofilaremic loiasis (> 8000 mf/ml for the treatment arm and under 8,000 mf/ml for the comparative arm) by blood microscopic direct examination 3. Signed written informed consent 4. Agree to comply with study procedures, including the provision of a blood sample and two stool samples at the beginning (baseline) and approximately six months after treatment 5. Willingness to stay in the village over the following 2 years
Exclusion criteria
Exclusion criteria: 1. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment and liver function tests 2. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease 3. Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before the screening 4. Known or suspected allergy to benzimidazoles 5. Pregnant (urine testing) or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 30 Adequate Clinical and Parasitological Response (ACPR) measured using parasitological diagnosis (direct examination and leukoconcentration techniques) for blood count of microfilariae, clinical diagnosis for the disappearance of loiasis symptoms and pharmacokinetic (PK) measurements with high-performance liquid chromatography (HPLC) on day 30 The ACPR corresponds to the reduction of microfilaraemia below the threshold of 8,000 mf/m without parasite recrudescence (recurrence). | — |
Secondary
| Measure | Time frame |
|---|---|
| Variables measured using parasitological diagnosis by direct examination and leukoconcentration techniques on blood samples: 1. Day 30 crude ACPR measured using microscopy on day 30 2. Day 60 crude ACPR measured using microscopy on day 60 3. Day 90 crude ACPR measured using microscopy on day 90 4. Day 180 total microfilaraemia clearance on day 180 5. Microfilaraemia at baseline then at 48 h, and on days 7, 14, 30, 60, 90, and 180 6. Time to microfilaraemia clearance per individual 7. Time to microfilaraemia reduction until 8,000 mf/ml 8. Time to recrudescence or re-infection, per individual 9. Observed microfilaraemia reduction rate (MRR) on days 7, 14, 30, 90, and 180 10. Observed frequency of soil-transmitted helminthiases (STH) at baseline and on day 90 after inclusion | — |
Countries
Gabon
Outcome results
None listed