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This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin for Yaws | Active Comparator | Patients will receive standard treatment for yaws alone |
|
| IDA for Lymphatic Filariasis | Active Comparator | Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone |
|
| Combination Therapy of Azithromycin for Yaws and IDA for LF | Experimental | Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Treatment with Azithromycin single dose - weight based dosing max 2gm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole | Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole | 4 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Patients will undergo regular monitoring for the duration of the study - adverse events will be graded from 1 to 4 in line with the CTCAE v4.0 | Four days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lihir Medical Centre | Londolovit | New Ireland Province | 034 | Papua New Guinea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37262040 | Derived | Alshehri A, Chhonker YS, Bala V, Edi C, Bjerum CM, Koudou BG, John LN, Mitja O, Marks M, King CL, Murry DJ. Population pharmacokinetic model of ivermectin in mass drug administration against lymphatic filariasis. PLoS Negl Trop Dis. 2023 Jun 1;17(6):e0011319. doi: 10.1371/journal.pntd.0011319. eCollection 2023 Jun. | |
| 32818264 | Derived |
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| ID | Term |
|---|---|
| D004605 | Elephantiasis, Filarial |
| D015001 | Yaws |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D015766 | Albendazole |
| D007559 | Ivermectin |
| D004049 | Diethylcarbamazine |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Albendazole | Drug | Single dose of Albendazole weight based dosing - 400mg |
|
|
| Ivermectin | Drug | Ivermectin weight based dosing - max 21mg |
|
|
| Diethylcarbamazine | Drug | Diethylcarbamazine weight based dosing - max 500mg |
|
|
| John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print. |
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |