Loiasis
Conditions
Interventions
Control group
Sponsors
Centre de Recherches Medicales de Lambarene CERMEL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Loa loa infection as evidenced by peripheral microfilaraemia assessed between 10am-4pm between 100-8,000 mf/ml • Both sexes, Aged 18 to 65 years, inclusive • Signed written informed consent • Intention to remain within the study period during entire period of the follow-up • Willingness to use culturally acceptable contraceptive measures for 1 month after treatment initiation • Willingness to use condom with spermicide for 90 days (approximately spermatogenesis cycle) after 1st IMP administration. • Willingness to use a highly effective method of contraception during treatment and until the end of relevant systemic exposure
Exclusion criteria
Exclusion criteria: • Ongoing participation in any interventional trial. • Known past or current history of neurological or neuropsychiatric disease or epilepsy (incl. previous meningitis, encephalitis) • History of drug or alcohol abuse • Any condition, in the investigator's opinion, that places the subject at undue risk (symptoms, physical signs or biological signs suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test.) or to significantly affect the study outcomes as judged by the investigator • Antifilarial therapy within previous 6 months (DEC, IVM, albendazole for more than 7 days) • History of severe drug-induced hypersensitivity reaction during previous medical treatment • Known intolerance to albendazole, mebendazole or Oxfendazole any of the excipients (including placebo) • Pregnant (assessed by urine pregnancy test) and breastfeeding women • Haemoglobin below 10mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is Safety and Tolerability of OXF in patients treated with loiasis during first 28 days post treatment for each dose level in the Intention To Treat Population (ITT). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is Pharmacodynamic characteristics of Oxfendazole against loiasis in Per Protocol Population (PP) one month after treatment. | — |
Countries
Gabon
Contacts
Public ContactLidwine Badjina
BNITM
Outcome results
None listed