Loiasis
Conditions
Interventions
Sponsors
Bernhard Nocht Institut for Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Both sexes, Aged 18 to 65 years, inclusive • Body weight = 40 kg • Good general condition, as determined by the medical questionnaire and clinical examination • Hematological parameters and adequate renal and hepatic functions, such as: o Leukocytes = 3,000 and = 11,300 cells/ml o Hemoglobin = 8.0 g/dl o Platelets =75,000/mm3 o Serum creatinine = 2.5 x ULN o Total bilirubinemia = 1.5 x ULN o ALT = 3.0 x ULN o AST = 3.0 x ULN o Negative urinary strip: absence of leukocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made for con-firmation) • Blood microfilarial density 1-1,000/ml or 1,000-2,000/ ml according to the recruit-ment cohort, respectively • Written, signed and dated informed con-sent of participant or impartial witness • Ability to take oral treatment and willing-ness to comply with the study procedures (covered by the informed consent)
Exclusion criteria
Exclusion criteria: • Ongoing participation in any interventional trial. • Any vaccination within 2 weeks before study drug administration • Acute infection requiring antibiotic therapy within the last 10 days before study drug administration • Concomitant administration of drugs of the benzodiazepine class (s. Annex) • Known past or current history of neurolog-ical 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 • Subjects who have donated blood within 8 weeks before study entry • Antifilarial therapy within the previous year (DEC, IVM, albendazole for more than 7 days) • History of severe drug-induced hypersensi-tivity reaction during previous medical treatment or mild to moderate hypersensi-tivity reaction to macrolytic lactones • Known intolerance to IVM, MOX or any of the excipients (including placebo) • Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •The primary purpose of this study is to determine the safety and tolerability of single dose 8 mg moxidectin (MOX) in subjects infected with L. loa compared to ivermectin (IVM). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the reduction of L. loa microfilarial density (MFD) after single dose MOX therapy to the reduction of MFD after single dose IVM or placebo • To compare the long-term duration of MFD reduction after single dose MOX to the any MFD reduction after single dose IVM or placebo by measuring monthly L.loa MFD over 18 months • To compare the reduction of patient-centred outcomes (clinical manifestations and eosinophil levels) over 18 months post MOX-treatment compared to IVM and placebo | — |
Countries
Gabon
Contacts
Public ContactLidiwne Badjina
Project Manager
Outcome results
None listed