Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidectin | Experimental |
| |
| Ivermectin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin 2 MG Oral Tablet | Drug | One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe adverse events post Moxidectin 2 mg | Absence of severe adverse events | 1 week |
| Incidence of adverse events with Moxidectin 2 mg | Proportion of adverse events during the first week | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy | Proportion of reduction of the microfilarial densities of Loa loa at Day 7 and Day 15 | Day 7 and Day 15 |
| Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT) | Yaoundé | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38966851 | Derived | Wafeu GS, Lepage TM, Campillo JT, Efon-Ekangouo A, Nana-Djeunga HC, Nzune-Toche N, Domche A, Sumo L, Njitchouang GR, Tsasse MAF, Bopda J, Balog YA, Niamsi-Emalio Y, Mbickmen-Tchana S, Talla GK, Kana YSN, Messina FDM, Pion SD, Kuesel AC, Kamgno J, Boussinesq M, Chesnais CB. Safety and Short-term Efficacy of a Single Dose of 2 mg Moxidectin in Loa loa-Infected Individuals: A Double-Blind, Randomized Ivermectin-Controlled Trial With Ascending Microfilarial Densities. Open Forum Infect Dis. 2024 Apr 25;11(7):ofae240. doi: 10.1093/ofid/ofae240. eCollection 2024 Jul. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ivermectin 3Mg Tab | Drug | 3 ivermectin tablets (or 4 according to the weight) will be blinded and will be administrated with 1 (or 0 according to the weight) tablet of placebo. |
|
| Placebo oral tablet | Drug | Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total. |
|
Proportion of reduction of the microfilarial densities of Loa loa at Day 80, Day 180, and Day 365 |
| Day 80, Day 180, and Year 1 |
| Percentage of individuals without microfilaria post Moxidectin 2 mg | Percentage of individuals without microfilariae of Loa loa at Day 7, Day 90, Day 180, and Day 365 | Day 7, Day 90, Day 180, and Year 1 |
| ID | Term |
|---|---|
| D015827 | Onchocerciasis, Ocular |
| D008118 | Loiasis |
| ID | Term |
|---|---|
| D015822 | Eye Infections, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D009855 | Onchocerciasis |
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D000079426 | Vector Borne Diseases |
| D015817 | Eye Infections |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C027837 | moxidectin |
| D013607 | Tablets |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided