Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa… (NCT04049851) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients
Cameroon72 participantsStarted 2022-04-07
Plain-language summary
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
Who can participate
Age range18 Years – 65 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent written, signed (or with a cross) and dated
* Men aged 18 to 65 included (women not included in the study)
* Microfilarial density between 1 and 1,000 mf/mL
* body weight ≥ 45 kg and less than 85 kg
* Good general condition, as determined by the medical questionnaire and clinical examination
* Hematological parameters and adequate renal and hepatic functions, such as:
* Leukocytes ≥ 2,800 and ≤ 11,300 cells/mL
* Hemoglobin ≥ 10.0 g/dL
* Platelets ≥100,000/mm3
* Serum creatinine ≤ 2.5 upper limit (UL) of the laboratory
* Total bilirubinemia ≤ 2.5 x UL
* ALAT ≤ 2.5 x UL
* Negative urinary strip: absence of leucocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made, for confirmation)
Exclusion Criteria:
* Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of MOX-2 mg or IVM).
* Person who has taken IVM in the last 6 months
* Any vaccination in the 4 weeks preceding this study
* Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
* Long-term antiretroviral therapy (protease inhibitor, non-nucleoside reverse transcriptase inhibitor), or treatment with ampicillin or chloramphenicol within 10 d…
What they're measuring
1
Incidence of severe adverse events post Moxidectin 2 mg
Timeframe: 1 week
2
Incidence of adverse events with Moxidectin 2 mg
Timeframe: 1 week
Trial details
NCT IDNCT04049851
SponsorCenter for Research on Filariasis and Other Tropical Diseases, Cameroon