Efficacy of albendazole in decreasing loa loa microfilaraemia
| ISRCTN | ISRCTN25831558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25831558 |
| Protocol serial number | A 60499 |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funders | GlaxoSmithKline (GSK) (International), World Bank Group, Bill and Melinda Gates Foundation (BMGF) (USA), African Programme for Onchocerciasis Control (APOC) (Burkina Faso) |
- Submission date
- 04/10/2006
- Registration date
- 04/10/2006
- Last edited
- 12/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annette C Kuesel
Scientific
Scientific
Special Programme for Research & Training in Tropical Diseases (TDR)
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 1541 |
|---|---|
| kuesela@who.int |
Joseph Kamgno
Scientific
Scientific
Coalition des ONGD Internationales contre l'Tonchocercose
Yaoundé
BP 4794
Cameroon
| Phone | +237 (0)778 97 36 |
|---|---|
| djoekam@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of albendazole in decreasing loa loa microfilaraemia |
| Study objectives | 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(s) | Cameroon Comite National d'Ethique/National Ethics Committee, 23/05/2006 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Albendazole |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 30/11/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Cameroon
- Switzerland
Study participating centre
Special Programme for Research & Training in Tropical Diseases (TDR)
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
