Trial · NCT02899936
Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis
NCT02899936, Not applicable, Completed, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis. Trials, record NCT02899936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02899936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis
- NCT number
- NCT02899936
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 23,789 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Lymphatic Filariasis
- Interventions
- 3 drug dose - IDA, 2 drug dose - DA
- First posted
- 2016-09-14
- Last updated
- 2020-12-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by modified CTCAE v4.0 scale | within 7 days of drug administration | To determine the frequency, type and severity of adverse events following triple-drug therapy Ivermectin, Diethylcarbamazine and Albendazole (IVM+DEC+ALB, IDA) compared to the standard two-drug treatment Diethylcarbamazine and Albendazole (DEC+ALB, DA) in infected and uninfected individuals in a community as assessed by modified CTCAE v4.0 scale. |
| Secondary | Number of participants with clearance of microfilaremia (MF) as measured with microfilaremia night blood smear testing (finger prick - 60ul) | baseline (pre-treatment), within 7 days of drug administration and follow up at 12 months | To compare the efficacy of IDA vs. DA administered in communities for clearance of MF and filarial antigenemia (Ag) in cohort and effectiveness (prevalence) in community settings. A minimum of 21 (70%) of MF-positive participants in each arm will be retested at 12 months post-treatment for antigenemia and microfilaremia. This sample size is adequate to demonstrate superiority of the IDA regimen (assumptions: 90% reduction in MF prevalence after IDA and 60% reduction after DA, 80% power for detecting an effect size of 30%). The primary endpoint for efficacy will be complete clearance of MF 12 months post Mass Drug Administration (MDA). Clearance of filarial antigenemia at 12 months will be a secondary endpoint for the efficacy analysis. Testing of microfilaria is by analyzing 60 microliter (ul) measured volume thick blood smear by finger prick method and results are either positive or negative for MF presence. |
| Secondary | Number of participants Filarial Test Strip (FTS) and/or MF positive as tested with FTS and night blood smears with treatment-related adverse events as assessed by modified CTCAE v4.0 scale | baseline (pre-treatment), within 7 days of drug administration and follow up at 12 months | To assess the presence and intensity of filarial infection on the frequency and severity of adverse events. One year post MDA, all participants who were positive for either microfilaremia or filarial antigenemia during the baseline visit will be tested for filarial antigen using the FTS to assess their response to treatment and to compare the efficacy of the two treatment regimens. Participants with positive FTS will also be tested for nocturnal microfilaremia by blood smear (finger prick - 60ul) |
| Secondary | Community acceptance will be measured using on a survey using likert scale questions based on perception of efficacy, intent to participate and relevance of the treatment. | 6-8 months | Community acceptance will be measured using a survey to community members receiving both the 2-drug and 3-drug treatments during the safety trial. To complement this survey, a series of focus group discussions in the community as well as key informant interviews are proposed with community leaders, health personnel and drug distributors in the same communities to assess perceptions about the 3-drug versus the 2-drug regimen. The community acceptability study will be carried out within one month of the completion of the safety trial. The acceptability score will use a set of likert scale questions based on perception of efficacy, intent to participate and relevance of the treatment. Some of the questions have been inspired by Reimer's Treatment Acceptability Rating form-Revised and general principles of social validity but mostly the questions are not from one particular survey instrument. |
| Secondary | Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment | Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence). | Some sites will include stool sample collections to compare the efficacy of 2 and 3-drug regimens on STH. Stool samples will be analysed using Kato-katz method, as well as PCR. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02899936
GET https://conductscience.org/api/trials/v1/NCT02899936/registered