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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201303000464219 Date registered: 2012/11/25
TRIAL DESCRIPTION
Public title Onchocerciasis Ocular Pathology post Ivermectin
Official scientific title Ocular Pathology in Onchocerciasis Patients Treated Annually with Ivermectin; A Cohort Study
Brief summary describing the background
and objectives of the trial
Onchocerciasis is a major cause for skin disease and ocular damage up to the stage of irreversible blindness. The only on large scale applicable onchocerciasis control measure is ivermectin treatment which has to be repeated annually. Replicated longitudinal surveys are required to determine the impact of ivermectin, and this cohort study examined the evolution and changes of ocular pathology in onchocerciasis patients treated annually with ivermectin for more than two decades.
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 1985-05-01
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up 2015-04-31
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants) 86   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Single group: all participants receive same intervention throughout study Non-randomised Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Ophthalmologic Examinations post Ivermectin Treatments Ivermectin 150ug/kg annually 30 years Slit lamp examination of the anterior eye segment and the eye fundus by ophthalmoscopy 200
Experimental group Ivermectin Treatment Ivermectin 150ug/kg annually 30 years Annual treatment with ivermectin (150ug/kg) 200

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Patients were apparently healthy males and non-pregnant women with a body weight over 30 kg, without history of multiple allergies or drug intolerance, with normal laboratory parameters except for the clinical features of onchocerciasis, with skin biopsies positive for microfilaria of O. volvulus and with palpable nodules (onchocercomata). Criteria for exclusion were allergies or drug intolerance, concomitant infection with Loa loa or Wuchereria bancrofti, haematocrit below 30%, renal or hepatic disease, convulsions or other central nervous system disease, clinical signs suggestive of meningitis, pregnant females or nursing mothers and patients who had received microfilaricidal drugs during the preceding year. 16 Years 55 Years Male

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes Togolese Ministry of Health (in 1987)
Ethics Committee Address
Street address City Postal code Country
Lomé Togo
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes Comite de Bioethiqe pour la Recherche en Santé (CBRS) (in 2011)
Ethics Committee Address
Street address City Postal code Country
Lomé Togo

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evolution and persistence of ocular pathology Before ivermectin treatment; 4 years post initial ivermectin treatment; 23 years post initial ivermectin treatment
Secondary Outcome Onchocerca volvulus skin microfilaria in patients post ivermectin treatments Before ivermectin treatment; 3 days post initial ivermectin treatment (p.i.t.); 3 months p.i.t.; 6 months p.i.t.; 12 months p.i.t.; 18 months p.i.t.; 4 years p.i.t.

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalier Regional Sokode B.P. 187 Togo

FUNDING SOURCES
Name of source Street address City Postal code Country
Commission of the European Communities (CT-TSD-002-D from 1984-1987) Control of Onchocerciasis Rue de la Loi 200 Brussels 1049 Belgium
GTZ - Gesellschaft für Technische Zusammenarbeit (from 1984-1989) CT 77.2210.1-01.100) Onchocerciasis Reference Laboratory Dag-Hammarskjöld-Weg 1-5 Eschborn 65760 Germany
Commission of the European Communities (TS3*920057; EC-INCO-DEV from 1992-1995) Rue de la Loi 200 Brussels 1049 Belgium
Commission of the European Communities (EC-INCO-SCOOTT-CT2006-032321: Sustainable Control of Onchocerciasis Today and Tomorrow) Rue de la Loi 200 Brussels 1049 Belgium
Merck Sharp & Dohme (from 1985 until 1989) : Ivermectin (MK-933) versus Placebo in Onchocerciasis Whitehouse Station New Jersey NJ 08889 United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Méba Banla, Université de Lomé, Centre Hospitalier Universitaire Campus, Lomé BP 25 Togo University
Secondary Sponsor Peter T. Soboslay, Institute for Tropical Medicine, University Clinics of Tübingen, Germany (from 1989-today) Wilhelmstr. 27 Tübingen 72074 Germany University
Primary Sponsor Dr. Dayoka Awissi (Director), Institut National d'Hygiene (from 1985-1989) Quartier administratif 77 rue Nangbéto Lomè BP 1396 Togo Foundation
Primary Sponsor Méba Banla, Université de Lomé, Centre Hospitalier Universitaire Campus, (from1989-today) Au sein de l'Université de Lomé (UL) Lomé BP 25 Togo University

COLLABORATORS
Name Street address City Postal code Country
Dr. Abiba Kére-Banla; Director; Institut National Hygiène Quartier Administratif 77 rue Nangbéto Lomé BP 1396 Togo
Dr. Potochoziou K. Karabou; Director; National Onchocerciasis Control Programme BP 236 Kara Togo

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Meba Banla meba.banla@gmail.com +228-902-2281
Street address City Postal code Country Position / Affiliation
Université de Lomé, Centre Hospitalier Universitaire Campus Lomé BP 1515 Togo Medecine Chef Service Ophtalmologie, CHU Campus
Role Name Email Phone Fax
Public Enquiries Dr Potochoziou K. Karabou karaboup@yahoo.fr +228-902-4795
Street address City Postal code Country Position / Affiliation
National Onchocerciasis Control Programme Kara BP 236 Togo Director of the National Onchocerciasis Control Program in Togo
Role Name Email Phone Fax
Scientific Enquiries Prof Peter T. Soboslay peter.soboslay@ uni-tuebingen.de +49-7071-2980230 +49-7071-295996
Street address City Postal code Country Position / Affiliation
Wilhelmstr. 27 Tübingen 72074 Germany Director of the Onchocerciasis Reference Laboratory ¿ Institut National d¿Hygiène, Sokodé, Togo