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This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III.
We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis.
The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEV 1 mg/kg | Experimental | Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
|
| LEV 1,5 mg/kg | Experimental | Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
|
| LEV 2,5 mg/kg | Experimental | Tablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
|
| Placebo | Placebo Comparator | Tablets of placebo will be administrated to the participant in single dose only one time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEV 1 mg/kg | Drug | A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of levamisole | Absence of severe adverse events during the first week | 1 week |
| Incidence of adverse events with levamisole | Proportion of adverse events during the first week | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of levamisole | Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1 | Day 2, Day 7, and Month 1 |
| Proportion of individuals without microfilariae of Loa loa |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population | Sibiti | Republic of the Congo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34651190 | Derived | Campillo JT, Bikita P, Hemilembolo M, Louya F, Missamou F, Pion SDS, Boussinesq M, Chesnais C. Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):19-27. doi: 10.1093/cid/ciab906. |
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| LEV 1,5 mg/kg | Drug | A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. |
|
| LEV 2,5 mg/kg | Drug | A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. |
|
| Placebo | Drug | 5 tablets of placebo will be administrated to the participants. |
|
Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1
| Day 7 and 1 Month |
| 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 |
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| ID | Term |
|---|---|
| D007978 | Levamisole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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