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Trial record 14 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis (DOLF-Indo)

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ClinicalTrials.gov Identifier: NCT01905423
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Gary Weil, MD, Washington University School of Medicine

Study Type Observational
Study Design Observational Model: Ecologic or Community;   Time Perspective: Cross-Sectional
Conditions Lymphatic Filariasis
Soil Transmitted Helminth Infections
Intervention Drug: Albendazole and diethylcarbamazine
Enrollment 19308
Recruitment Details This was a cross-sectional study. The final end points of the study are measures of community prevalence. Participant involvement in the study ended after each survey period. Participants were not followed across survey periods, but could be and were likely recruited into more than one survey period.
Pre-assignment Details  
Arm/Group Title Annual MDA Treated Group Semiannual MDA Treated Group Annual MDA Treated Group (Pekalongan) Semiannual MDA Treated Group (Pekalongan)
Hide Arm/Group Description

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

The Pekalongan study site was dropped from further analysis after teh first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive annual MDA (Albaendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesia Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Ablendazole 400 mg plus diethylcarbamzine 6 mg/kg once yearly vs twice yearly

The Pekalongan study site was dropped from further analysis after teh first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive semiannual MDA (Albaendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesia Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Ablendazole 400 mg plus diethylcarbamzine 6 mg/kg once yearly vs twice yearly

Period Title: Overall Study
Started 7753 4111 4119 3324
Baseline 2165 1033 2082 1634
Year 1 Follow-up 1840 1007 2037 1690
Year 2 Follow-up 1972 1043 0 0
Year 3 Follow-up 1776 1028 0 0
Completed 7753 4111 4119 3324
Not Completed 0 0 0 0
Arm/Group Title Annual MDA Treated Group Semiannual MDA Treated Group Annual MDA Treated Group (Pekalongan) Semiannual MDA Treated Group (Pekalongan) Total
Hide Arm/Group Description

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

Total of all reporting groups
Overall Number of Baseline Participants 2165 1033 2082 1634 6914
Hide Baseline Analysis Population Description
The baseline analysis is presented separately for the Pekalongan study site. This study site was dropped from further study following the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2164 participants 1033 participants 2080 participants 1634 participants 6911 participants
27.47
(5 to 87)
27.82
(5 to 83)
27.43
(5 to 87)
28.87
(5 to 84)
27.84
(5 to 87)
[1]
Measure Analysis Population Description: Two participants in the once annual MDA treatment from Pekalongan had ages outside of the inclusion criteria.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2164 participants 1033 participants 2006 participants 1634 participants 6837 participants
Female
1308
  60.4%
545
  52.8%
1087
  54.2%
896
  54.8%
3836
  56.1%
Male
856
  39.6%
488
  47.2%
919
  45.8%
738
  45.2%
3001
  43.9%
[1]
Measure Analysis Population Description: Gender data missing for some participants.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Indonesia Number Analyzed 2165 participants 1033 participants 2082 participants 1634 participants 6914 participants
2165 1033 2082 1634 6914
LF Microfilaria Prevalence   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2112 participants 1027 participants 1470 participants 1295 participants 5904 participants
90
   4.3%
146
  14.2%
48
   3.3%
45
   3.5%
329
   5.6%
[1]
Measure Analysis Population Description: Some participants have missing microfilaria data and are not included in the analysis.
Lymphatic Filariasis Antigen Prevalence (ICT)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2124 participants 1015 participants 2045 participants 1541 participants 6725 participants
61
   2.9%
232
  22.9%
149
   7.3%
112
   7.3%
554
   8.2%
[1]
Measure Analysis Population Description: Some participants have missing microfilaria data and are not included in the analysis.
Prevalence of worm eggs in stool   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 111 participants 731 participants 682 participants 2017 participants
372
  75.5%
63
  56.8%
199
  27.2%
335
  49.1%
969
  48.0%
[1]
Measure Analysis Population Description: Some participants did not provide stool samples to measure prevalence of worm eggs.
1.Primary Outcome
Title Microfilaria Prevalence in Blood by Microscopy
Hide Description Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual community surveys. Microfilaremia is a categorical variable (positive or negative). Prevalence rates are expressed as % positive.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis excludes participants from Pekalongan study site that were dropped after the first follow-up due to lower than expected filariasis prevalence.
Arm/Group Title Annual MDA Treated Group Semiannual MDA Treated Group
Hide Arm/Group Description:

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

Overall Number of Participants Analyzed 1776 1027
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.2%
12
   1.2%
2.Secondary Outcome
Title Filarial Antigenemia in Blood and Worm Parasite Eggs in Stool by Microscopy
Hide Description Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these prevalence outcomes are qualitative with no units of measure (positive or negative). Prevalence date are expressed as % positive. Other secondary outcome measures will be intensity of parasite infections (microfilariae per ml of blood and the number of worm eggs per gram of stool).
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants were tested for antigen or provided stool to determine prevalence of worm eggs.
Arm/Group Title Annual MDA Treated Group Semiannual MDA Treated Group
Hide Arm/Group Description:

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

Overall Number of Participants Analyzed 1776 1027
Measure Type: Count of Participants
Unit of Measure: Participants
Filaria Antigenemia Number Analyzed 839 participants 982 participants
3
   0.4%
12
   1.2%
Prevalence of worm eggs in stool Number Analyzed 905 participants 753 participants
414
  45.7%
394
  52.3%
Time Frame Subjects will be monitored for adverse events related to blood collection at each year of observation.
Adverse Event Reporting Description This is a minimal risk and nonintervention study. Adverse events are not expected to be an issue. However, subjects will be monitored for adverse events related to blood collection.
 
Arm/Group Title Annual MDA Treated Group Semiannual MDA Treated Group
Hide Arm/Group Description

This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.

Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly

All-Cause Mortality
Annual MDA Treated Group Semiannual MDA Treated Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11872 (0.00%)   0/7435 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Annual MDA Treated Group Semiannual MDA Treated Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11872 (0.00%)   0/7435 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Annual MDA Treated Group Semiannual MDA Treated Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11872 (0.00%)   0/7435 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Fischer
Organization: Washington University in St Louis Medical School
Phone: +1 (314) 747-5198
EMail: pufischer@wustl.edu
Layout table for additonal information
Responsible Party: Gary Weil, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01905423     History of Changes
Other Study ID Numbers: 201103313
First Submitted: April 11, 2012
First Posted: July 23, 2013
Results First Submitted: May 24, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017