Condition category
Infections and Infestations
Date applied
04/10/2006
Date assigned
04/10/2006
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int

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

Publication citations

Additional files

Editorial Notes