Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02929134
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2016-10-07
Brief Title:
A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka
Sponsor:
The Task Force for Global Health
Organization:
The Task Force for Global Health
Study Overview
Official Title:
A Multi-center Double-blind Randomized 24-month Study to Compare the Efficacy of Doxycycline Once Daily for 6 Weeks Versus Placebo in Improving Filarial Lymphedema Independent of Active Filarial Infection
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LeDoxy-SL
Brief Summary:
Current lymphedema management protocols are based on the use of simple measures of hygiene regular washing with soap and water skin and nail care use of topical antibiotics or antifungal agents exercise and footwear This is considered the standard of care in most endemic countries in the absence of any structured treatment programs Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis ADLA that drive the progression of lymphedema
In the present study the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline look-alike placebo tablets However both groups will be enrolled into a standardized regimen of hygiene described above Thus patients enrolled in the placebo group also will receive the current standard of care and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment In addition patients will be evaluated at 3 6 12 and 24 months A common generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites
In the present study the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline look-alike placebo tablets However both groups will be enrolled into a standardized regimen of hygiene described above Thus patients enrolled in the placebo group also will receive the current standard of care and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment In addition patients will be evaluated at 3 6 12 and 24 months A common generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites
Detailed Description:
This LEDOXY trial is designed as a randomized controlled observer- provider- and patient-blinded multicenter superiority trial with two parallel groups and a primary endpoint of change in grade of lymphedema at 24 months The population will be stratified according to the Grade Early Grade 1-3 Late Grade 4-6 Randomization will be performed as block randomization within each center in blocks of N4-10 for each of the groups Early and Late
The effect of a 6-week course doxycycline on lymphedema without active filarial infection has been demonstrated in a single setting in Africa Ghana In order to expand the benefits of this observation similar studies need to be carried out in other endemic settings Lymphatic filariasis is endemic in many countries of Africa and Asia that are yet to implement morbidity management programmes In addition the components of the proposed hygiene package are likely to vary depending on the availability of material and human resources The conduct of this trial as a multi-center study will not only allow the evaluation of the efficacy of the drug in a variety of settings but also facilitate its rapid adoption by the respective control programmes of endemic countries if proven to be useful
The choice of study sites in endemic countries has been made based on the availability of a adequate numbers of patients with various grades of lymphedema and b clinical trial teams familiar with lymphedema management procedures and past experience with similar trials
All screened patients will be enrolled into a programme of hygiene described below and will be required to demonstrate ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment Eligible patients will be randomized to receive either daily doxycycline or placebo Doxycycline and placebo will be provided by Medopharm India Re-labeling and packaging of the drug and the placebo will be done by Piramal Healthcare Morpeth UK Additionally after un-blinding and data analysis the placebo group will be offered doxycycline treatment if the intervention proves to be more effective in ameliorating LE
Both doxycycline and placebo will be administered under supervision directly observed treatment for 6 weeks The first dose of doxycycline two 100 mg tablets for those over 50kg body weight and one 100 mg tablets for those between 40 and 50 kg body weight or placebo will be given after all the investigations have been completed and informed consent has been obtained and the patient has been initiated into the programme of basic hygiene Patients will be encouraged to eat before swallowing the tablets whole with a glass of water Vomited doses will be replaced
Ideally patients will be required to come every day to the closest community health center to take their drugs under supervision Subjects living in villages at a distance from any health center will be treated by the community health care provider or the local caregiver living in this village who will be informed and trained in the possible adverse events related to the drug
Since some study sites may be village based without a health centre patients may be treated in their village and required to attend daily at a fixed meeting point The trial clinician and the research team with the help of trained community health workers will normally administer the treatment Patients should come to the clinic every week with the patient and collect the drugs for one week The provider will keep a diary where he or she will mark down the time of intake of the drug A health worker may make surprise checks at the patients residence by looking at the diary and also by counting the remaining drugs to estimate compliance
The effect of a 6-week course doxycycline on lymphedema without active filarial infection has been demonstrated in a single setting in Africa Ghana In order to expand the benefits of this observation similar studies need to be carried out in other endemic settings Lymphatic filariasis is endemic in many countries of Africa and Asia that are yet to implement morbidity management programmes In addition the components of the proposed hygiene package are likely to vary depending on the availability of material and human resources The conduct of this trial as a multi-center study will not only allow the evaluation of the efficacy of the drug in a variety of settings but also facilitate its rapid adoption by the respective control programmes of endemic countries if proven to be useful
The choice of study sites in endemic countries has been made based on the availability of a adequate numbers of patients with various grades of lymphedema and b clinical trial teams familiar with lymphedema management procedures and past experience with similar trials
All screened patients will be enrolled into a programme of hygiene described below and will be required to demonstrate ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment Eligible patients will be randomized to receive either daily doxycycline or placebo Doxycycline and placebo will be provided by Medopharm India Re-labeling and packaging of the drug and the placebo will be done by Piramal Healthcare Morpeth UK Additionally after un-blinding and data analysis the placebo group will be offered doxycycline treatment if the intervention proves to be more effective in ameliorating LE
Both doxycycline and placebo will be administered under supervision directly observed treatment for 6 weeks The first dose of doxycycline two 100 mg tablets for those over 50kg body weight and one 100 mg tablets for those between 40 and 50 kg body weight or placebo will be given after all the investigations have been completed and informed consent has been obtained and the patient has been initiated into the programme of basic hygiene Patients will be encouraged to eat before swallowing the tablets whole with a glass of water Vomited doses will be replaced
Ideally patients will be required to come every day to the closest community health center to take their drugs under supervision Subjects living in villages at a distance from any health center will be treated by the community health care provider or the local caregiver living in this village who will be informed and trained in the possible adverse events related to the drug
Since some study sites may be village based without a health centre patients may be treated in their village and required to attend daily at a fixed meeting point The trial clinician and the research team with the help of trained community health workers will normally administer the treatment Patients should come to the clinic every week with the patient and collect the drugs for one week The provider will keep a diary where he or she will mark down the time of intake of the drug A health worker may make surprise checks at the patients residence by looking at the diary and also by counting the remaining drugs to estimate compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None