NCT04049851CompletedPhase 2
Randomized Clinical Trial, Double-blind, Single-dose Drug and Escalating Infection Intensities, Evaluating the Safety and Efficacy of Moxidectin 2 Mg, Ivermectin-controlled, in Loa Loa Microfilaremic Patients
Center for Research on Filariasis and Other Tropical Diseases, Cameroon1 site in 1 country72 target enrollmentStarted: April 7, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of severe adverse events post Moxidectin 2 mg
Study Overview
Brief Summary
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
Detailed Description
This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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 days prior to administration of the test drug
- •History or presence of neurological (including epilepsy) or neuropsychiatric disease
- •Excessive consumption of alcohol or other drug abuse within 72 hours prior to the administration of the test treatment determined by the medical history during the medical interview.
- •Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
- •Subjects who donated blood in the 8 weeks prior to study entry, with a standard volume (> 500 mL)
- •Known intolerance to IVM, MOX or any of the excipients (including placebo)
- •During the clinical examination: symptoms, physical signs or biological constants 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. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant
Arms & Interventions
Ivermectin
Active Comparator
Intervention: Ivermectin 3Mg Tab (Drug)
Moxidectin
Experimental
Intervention: Moxidectin 2 MG Oral Tablet (Drug)
Moxidectin
Experimental
Intervention: Placebo oral tablet (Drug)
Ivermectin
Active Comparator
Intervention: Placebo oral tablet (Drug)
Outcomes
Primary Outcomes
Incidence of severe adverse events post Moxidectin 2 mg
Time Frame: 1 week
Absence of severe adverse events
Incidence of adverse events with Moxidectin 2 mg
Time Frame: 1 week
Proportion of adverse events during the first week
Secondary Outcomes
- Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy(Day 80, Day 180, and Year 1)
- Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy(Day 7 and Day 15)
- Percentage of individuals without microfilaria post Moxidectin 2 mg(Day 7, Day 90, Day 180, and Year 1)
Investigators
Study Sites (1)
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