Efficacy of albendazole in decreasing loa loa microfilaraemia

Not Applicable

Completed

Conditions: oiasis
Infections and Infestations

Registration Number: ISRCTN25831558

Lead Sponsor: ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. 18 to 65 year old male or female.
2. Loa Loa Microfilaremia (LLM) greater than 15000 mf/ml as determined by calibrated blood smear
3. Do not plan on moving out of the area over the next two years
4. Given informed consent (written, witnessed, signed or thumb printed)

Exclusion Criteria

1. Treatment with a benzimidazole during the last 12 months
2. Self-reported allergy to benzimidazoles
3. Pregnancy, assessed by urine pregnancy test (Beta-Human Chorionic Gonadotropin [ß-HCG]) before each treatment in all women of child-bearing potential
4. Clinical signs and symptoms and laboratory evidence of intestinal helminths
5. Any serious underlying medical condition
6. Past or current history of neurological or neuropsychiatric disorders
7. Clinical and/or laboratory evidence of significant liver disease, kidney disease or anaemia or any other condition that in the investigator's judgment should exclude the subject from the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with microfilaria count sustainably reduced by 50% from the baseline value at any time point after the first dose. A sustainable reduction by 50% is defined as a reduction to 50% of baseline LLM for at least four months.

Secondary Outcome Measures

Name	Time	Method
1. Proportion of subjects with microfilaria counts reduced sustainably to less than 8100 mf/ml at any time point after first dose by microfilaria count at baseline, by gender<br>2. Percent reduction in microfilaria counts at each time point quantitated via the range, William geometric mean and median by treatment group, initial microfilaria level and gender<br>3. Evolution of loa parasitemia with time in each treatment group analysed via General Linear Model