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| ID | Type | Description | Link |
|---|---|---|---|
| 0958/FMPOS | Other Identifier | FMPOS |
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| Name | Class |
|---|---|
| International Trachoma Initiative | OTHER |
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The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.
Infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of Africa and Asia. Elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient.
Thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co endemic for lymphatic filariasis and trachoma.
It was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs.
Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple co administration at once of the combination of Albendazole + ivermectin + azithromycin | Drug | Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the incidence of adverse events associated with the mass triple drug administration | From Day 0 to Day 15 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the incidence of serious adverse events associated with the mass triple drug administration | From Day 0 to Day 15 post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samba O Sow, MD, MPH | CNAM, Mali | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National D'Appui a la lutte contre la Maladie | Bamako | Mali | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23675549 | Derived | Coulibaly YI, Dicko I, Keita M, Keita MM, Doumbia M, Daou A, Haidara FC, Sankare MH, Horton J, Whately-Smith C, Sow SO. A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali. PLoS Negl Trop Dis. 2013 May 9;7(5):e2221. doi: 10.1371/journal.pntd.0002221. Print 2013. |
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| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D001424 | Bacterial Infections |
| D004605 | Elephantiasis, Filarial |
| D014141 | Trachoma |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001423 | Bacterial Infections and Mycoses |
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| D002690 | Chlamydia Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D017963 | Azithromycin |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004917 | Erythromycin |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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