Onchocerciasis Infections and Infestations Onchocerciasis
Conditions
Interventions
Two types of Diethylcarbamazine (DEC) patches (Onchocerciasis Control Programme [OCP] and Lohmann Therapie-System [LTS]) applied to two groups each of 15 subjects. OCP applied on day one to one iliac
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males in good general health, with O. volvulus infection 2. Written, signed and dated informed consent 3. Age 18 to 55 years 4. Weight over 40 kg 5. Healthy as determined by medical history, physical exam, Electrocardiogram (ECG) and clinical lab results 6. Adequate lab functions: 6.1. White Blood Cell count (WBC) more than 3,500 and 12,000 cells/ml 6.2. Haemogloblin (Hb) more than 11.0 g/dl 6.3. Platelets count more than 110,000 mm^3 6.4. Serum creatinine less than 1.25 x Upper Limit of Normal (ULN) 6.5. Total bilirubin less than 1.25 x ULN 6.6. Aspartate Transaminase (AST)/Serum Glutamic Oxaloacetic Transaminase (SGOT) less than 1.25 x ULN 6.7. Alkaline Phosphatase (AP) more than 1.25 x ULN 7. Skin microfilarial (mf) density of 5 to 15 mg as determined at the iliac crests
Exclusion criteria
Exclusion criteria: 1. Ocular onchocerciasis 2. Hyper-reactive onchodermatitis 3. Skin lesions over iliac crests 4. Coincidental infection with Mansonella streptocera 5. Significant Electrocardiogram (ECG) abnormalities or history of cardiac abnormality 6. History of drug or alcohol abuse 7. Any other condition that the investigator feels would exclude the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety, tolerability and potential utility under field conditions for the diagnosis of onchocerciasis of the LTS patch 2 prototype in subjects known to be infected with Onchocerca volvulus. The utility of LTS patch 2 for field use will depend on the ease of preparation, application and readout of the results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the positive reaction rates of the OCP and LTS patches as determined at 24 and 30 hours after application 2. To determine the underlying pathology of the skin reactions from the histopathology of skin punch biopsies taken from selected subjects | — |
Countries
Ghana
Outcome results
None listed