Efficacy of albendazole in decreasing loa loa microfilaraemia

ISRCTN	ISRCTN25831558
DOI	https://doi.org/10.1186/ISRCTN25831558
Secondary identifying numbers	A 60499

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

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
Email	kuesela@who.int

Dr Joseph Kamgno
Scientific

Coalition des ONGD Internationales contre l'Tonchocercose
Yaoundé
BP 4794
Cameroon

Phone	+237 (0)778 97 36
Email	djoekam@hotmail.com

Study information

Study design	Randomised clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Albendazole
Primary outcome measure	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 study start date	30/11/2006
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	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

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Industry

GlaxoSmithKline (GSK) (International)
Government organisation / For-profit companies (industry)

Alternative name(s): GlaxoSmithKline plc., GSK plc., GSK
Location: United Kingdom

World Bank Group
Private sector organisation / International organizations

Alternative name(s): World Bank, The World Bank, Grupo Banco Mundial, Banco Mundial, Groupe Banque Mondiale, Banque Mondiale, مجموعة البنك الدولي, Группа Всемирного банка, 世界银行, WBG
Location: United States of America

Bill and Melinda Gates Foundation (BMGF) (USA)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location: United States of America

African Programme for Onchocerciasis Control (APOC) (Burkina Faso)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan