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
Not provided
Not provided
Not provided
Not provided
Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as standard treatment for the clearance of W. bancrofti infection. It takes about one year for the individuals to completely clear the microfilaria from the blood. It takes another two to four years to clear the antigen. The aim of the present study is to shorten the time taken for clearing the Mf and antigen from the blood either by co-administration or sequential administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a randomized, double blind, controlled clinical trial to study the efficacy of these drug combinations in complete clearance the Mf and antigen from the blood in shorter span of 180 days and 365 days respectively.
Purpose:
Lymphatic dwelling parasite W. bancrofti is the most common cause of secondary lymphoedema. Till today, there is no effective treatment protocol for the complete clearance of W. bancrofti infection, in a short duration of time.
Methods:
The investigators conducted a double blind RCT under field conditions recruiting 146 asymptomatic W. bancrofti infected individuals. Participants were randomly assigned one of the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg co-administration or DEC 300 mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential administration or control regimen DEC 300 mg. Participants were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEC + ALB sequential | Experimental | Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially |
|
| DEC + ALB co-admin | Experimental | Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days |
|
| DEC + DOXY co-admin | Experimental | Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days |
|
| Diethylcarbamazine (DEC) | Active Comparator | Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diethylcarbamazine | Drug | Diethylcarbamazine 300 mg tablet as single dose per day for 12 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete clearance of mf in 80% of the infected | At 13th week (91 days) post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance Mf and complete clearance of antigen from the infected | a)Complete clearance of Mf by 26 weeks (180 days) post therapy. b) Complete clearance of antigen by 52 weeks (365days) post therapy | 26 and 52 weeks post therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lourduraj J De Britto, M.D | Vector Control Research Centre, Indian Council of Medical Research, Pondicherry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vector Control Research Centre | Puducherry | Puducherry | 605006 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26691247 | Derived | De Britto RL, Vanamail P, Sankari T, Vijayalakshmi G, Das LK, Pani SP. Enhanced efficacy of sequential administration of Albendazole for the clearance of Wuchereria bancrofti infection: Double blind RCT. Trop Biomed. 2015 Jun;32(2):198-209. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D004605 | Elephantiasis, Filarial |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D004049 | Diethylcarbamazine |
| D015766 | Albendazole |
| D000418 | Albumins |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Albendazole | Drug | Experimental |
|
|
| Doxycycline | Drug | Experimental |
|
|
| D009349 |
| Nematode Infections |
| D006373 | Helminthiasis |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| 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 |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |