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This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.
This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.
There will be 3 treatment arms as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment | Active Comparator | Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months). |
|
| DEC 6 mg/kg + Alb 400 mg x 1 | Experimental | Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once |
|
| DEC + ALB + IVM | Experimental | Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diethylcarbamazine | Drug | Diethylcarbamazine 6mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) | at 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with total clearance of Mf at 24 months. | 24 months | |
| Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months | 24 months and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Siba, PhD | Papua New Guinea Institution for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papua New Guinean Institute for Medical Research | Maprik | East Sepik Province | Papua New Guinea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30403937 | Derived | King CL, Suamani J, Sanuku N, Cheng YC, Satofan S, Mancuso B, Goss CW, Robinson LJ, Siba PM, Weil GJ, Kazura JW. A Trial of a Triple-Drug Treatment for Lymphatic Filariasis. N Engl J Med. 2018 Nov 8;379(19):1801-1810. doi: 10.1056/NEJMoa1706854. | |
| 26486704 | Derived | Thomsen EK, Sanuku N, Baea M, Satofan S, Maki E, Lombore B, Schmidt MS, Siba PM, Weil GJ, Kazura JW, Fleckenstein LL, King CL. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20. |
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| Albendazole | Drug | Albendazole 400mg |
|
|
| Ivermectin | Drug | Ivermectin 200 mcg/kg |
|
|
| Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study | 24 months and 36 months |
| ID | Term |
|---|---|
| D004605 | Elephantiasis, Filarial |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| 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 |
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| ID | Term |
|---|---|
| D004049 | Diethylcarbamazine |
| D015766 | Albendazole |
| D000418 | Albumins |
| D007559 | Ivermectin |
| D000069416 | Intravital Microscopy |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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