Contact information
Type
Scientific
Primary contact
Dr Annette C Kuesel
ORCID ID
Contact details
Special Programme for Research & Training in Tropical Diseases (TDR)
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 1541
kuesela@who.int
Type
Scientific
Additional contact
Dr Joseph Kamgno
ORCID ID
Contact details
Coalition des ONGD Internationales contre l'Tonchocercose
Yaoundé
BP 4794
Cameroon
+237 (0)778 97 36
djoekam@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A 60499
Study information
Scientific title
Efficacy of albendazole in decreasing loa loa microfilaraemia
Acronym
Study hypothesis
Two or six doses of albendazole administered at two months intervals result in significant reduction in loa loa microfilaremia and are safe and well tolerated.
Ethics approval
Cameroon Comite National d'Ethique/National Ethics Committee, 23/05/2006
Study design
Randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Loiasis
Intervention
Group one: 800 mg albendazole at zero and two months (total of two doses), then placebo at four, six, eight and ten months (total of four doses)
Group two: 800 mg albendazole at zero, two, four, six, eight and ten months (total of six doses)
Group three: Placebo at zero, two, four, six, eight and ten months (total of six doses)
Intervention type
Drug
Phase
Not Applicable
Drug names
Albendazole
Primary outcome measures
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
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
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
3. Evolution of loa parasitemia with time in each treatment group analysed via General Linear Model
Overall trial start date
30/11/2006
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
30/11/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Cameroon
Trial participating centre
Special Programme for Research & Training in Tropical Diseases (TDR)
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (GSK) (International)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
World Bank Group
Alternative name(s)
World Bank
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United States of America
Funder name
Bill and Melinda Gates Foundation (BMGF) (USA)
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Funder name
African Programme for Onchocerciasis Control (APOC) (Burkina Faso)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary