Loiasis
Conditions
Interventions
P tablets
Ivermectin
Albendazole
Sponsors
Bernhard Nocht Institute for Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants of either sex (=18 years) - Intention to remain residing in study area and comply with study procedures throughout the follow-up period - Positive RAPLOA assessment within the last years - Signed written informed consent
Exclusion criteria
Exclusion criteria: - mf - Known intolerance or allergy to any study drug - Known acute viral hepatitis (HBV, HCV) or other known acute active liver disease - Known acute HIV infection or other known immunosuppressive condition - History of epilepsy, encephalitis, meningitis or encephalopathy, severe alcohol abuse - Any other acute or chronic medical condition, medication or psychosocial factor(s) deemed by the Investigator to put the potential participant at greater than acceptable risk or to significantly affect study outcomes - Pregnancy, breastfeeding, and unwillingness to use any type of contraceptive method for women with childbearing potential - Any anti-filarial treatment in the past 4 weeks (ivermectin, >5 days of albendazole or mebendazole, DEC, >3 weeks of doxycycline or tetracycline) - Uncomplicated loiasis (as evidence by absence of end organ complications: signs or symptoms of end organ complication including heart failure, respiratory distress, or renal insufficiency) - Abusive alcohol consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority trial of treatment regimens compared to placebo for PROMs (relative reduction of composite PROMs) at DT+ 7, 28,month 3 and 6 after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety and tolerability assessed by the occurrence of all adverse events (AE) at least possibly related to study drug up to day 28 - Patient-centred efficacy assessed by a- The proportion of participants with symptoms possibly related to loiasis during the study period at baseline, at DT+ 7, 28, month 3 and 6 after treatment initiation b- The median reduction (IQR) of eosinophile count at DT+1, 3, 7, 14, 21, 28, 2, 3, and 6 months after treatment initiation and at nadir | — |
Countries
Gabon
Contacts
Public ContactSaskia;Cedric Davi;Mbavu
Scientific Research Staff in Clinical Research Departement at the Bernhard Nocht Institute for Tropical Medicine;Project Manager in Clinical Research Department at the Bernhard Nocht Institute for Tropical Medicine
Outcome results
None listed