Filarial; InfestationPhase 4NCT02005653
Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection
A Phase 4 study testing Diethylcarbamazine, Albendazole and Doxycycline in people with Filarial; Infestation, run by Indian Council of Medical Research at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Filarial; Infestation
- What is being tested?
- Diethylcarbamazine, Albendazole and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residing in or around Pondicherry and adjoining Tamilnadu areas
- Night blood microfilaria counts > 10 mf/ml by membrane filtration
- No history of treatment for filarial infection for the last two years at least
- Willing for home visits by the staff of the center
- Willing to give written informed consent
Who cannot join
- Body weight less than 30 kg
- Hepatic or renal disease as evidenced by clinical or biochemical abnormalities. - concurrent illness like hypertension, diabetes mellitus, cardiac conditions and epilepsy requiring chronic medication
- Psychiatric illness
- Patients under tetracycline or doxycycline therapy
- History of de-worming by albendazole or other anti-helminthic during last one year
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection: Double Blind Randomised Clinical Trial (RCT) to Study the Efficacy of Different Co-administration and Sequential Administration
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.
Read the detailed description
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.
- Conditions
- Filarial; Infestation
- Being tested
- Diethylcarbamazine, Albendazole, Doxycycline
- Keywords
- Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline
- Medical subject headings
- Parasitic Diseases, Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiethylcarbamazineDrug
Also called DEC
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
AlbendazoleDrug
Also called Alb
Experimental
DoxycyclineDrug
Also called Doxy
Experimental
| Study group | Role | What they receive |
|---|---|---|
| DEC + ALB sequential | Experimental | Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially Receives: Drug: Diethylcarbamazine; Drug: Albendazole |
| DEC + ALB co-admin | Experimental | Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days Receives: Drug: Diethylcarbamazine; Drug: Albendazole |
| DEC + DOXY co-admin | Experimental | Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days Receives: Drug: Diethylcarbamazine; Drug: Doxycycline |
| Diethylcarbamazine (DEC) | Active comparator | Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days Receives: Drug: Diethylcarbamazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete clearance of mf in 80% of the infected
Measured: At 13th week (91 days) post therapy
Secondary outcomes (1)
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
Measured: 26 and 52 weeks post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Filarial; InfestationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lourduraj John De Britto, Indian Council of Medical Research
- Investigators
- Lourduraj J De Britto, M.D, Principal investigator, Vector Control Research Centre, Indian Council of Medical Research, Pondicherry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005653
- Sponsor's protocol ID
- IM0603-CEC-VCRC
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26691247
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection: Double Blind Randomised Clinical Trial (RCT) to Study the Efficacy of Different Co-administration and Sequential Administration
- ClinicalTrials.gov ID
- NCT02005653
- Acronym / sponsor ID
- IM0603-CEC-VCRC
- Conditions
- Filarial; Infestation
- Keywords
- Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DEC + ALB sequential | Experimental | Drug: Diethylcarbamazine, Drug: AlbendazoleDiethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially |
| DEC + ALB co-admin | Experimental | Drug: Diethylcarbamazine, Drug: AlbendazoleDiethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days |
| DEC + DOXY co-admin | Experimental | Drug: Diethylcarbamazine, Drug: DoxycyclineDiethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days |
| Diethylcarbamazine (DEC) | Active comparator | Drug: DiethylcarbamazineDiethylcarbamazine 300 mg tablet as single dose orally per day for 12 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Residing in or around Pondicherry and adjoining Tamilnadu areas
- Night blood microfilaria counts > 10 mf/ml by membrane filtration
- No history of treatment for filarial infection for the last two years at least
- Willing for home visits by the staff of the center
- Willing to give written informed consent
Key exclusion criteria (6 listed)
- Body weight less than 30 kg
- Hepatic or renal disease as evidenced by clinical or biochemical abnormalities. - concurrent illness like hypertension, diabetes mellitus, cardiac conditions and epilepsy requiring chronic medication
- Psychiatric illness
- Patients under tetracycline or doxycycline therapy
- History of de-worming by albendazole or other anti-helminthic during last one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiethylcarbamazineAlso: DECDiethylcarbamazine 300 mg tablet as single dose per day for 12 days | Drug | DEC + ALB co-admin, DEC + ALB sequential, DEC + DOXY co-admin, Diethylcarbamazine (DEC) |
| AlbendazoleAlso: AlbExperimental | Drug | DEC + ALB co-admin, DEC + ALB sequential |
| DoxycyclineAlso: DoxyExperimental | Drug | DEC + DOXY co-admin |
Primary outcome
complete clearance of mf in 80% of the infected
Time frame: At 13th week (91 days) post therapy
1 secondary outcome
Complete clearance Mf and complete clearance of antigen from the infected
Time frame: 26 and 52 weeks post therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 26691247De 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.
Related trials for Filarial; Infestation
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourduraj J De Britto, M.D principal investigator
Vector Control Research Centre, Indian Council of Medical Research, Pondicherry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diethylcarbamazine, Albendazole and Doxycycline in people with Filarial; Infestation, run by Indian Council of Medical Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete clearance of mf in 80% of the infected (time frame: At 13th week (91 days) post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.