Lymphatic FilariasesFITNCT03177993
Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
A study testing 3 drug dose - IDA, 3 drug dose - IDA with second dose of ivermectin and 2 drug dose - DA in people with Lymphatic Filariases and Scabies, run by Washington University School of Medicine at 1 site in Fiji.
Trial summary
Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariases, Scabies, Impetigo
- What is being tested?
- 3 drug dose - IDA, 3 drug dose - IDA with second dose of ivermectin and 2 drug dose - DA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,773 participants
- Where
- 1 siteFiji
- Study dates
- 13 Jul 2017to 24 Oct 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All community members that have given written informed consent to participate
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
Fiji1 site
Ministry of Health and Medical Services
Suva
About this study
Official title: Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) Versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required.
In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy.
Read more
Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomized study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed.
In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.
- Conditions
- Lymphatic Filariases, Scabies, Impetigo, Soil Transmitted Helminths
- Being tested
- 3 drug dose - IDA, 3 drug dose - IDA with second dose of ivermectin, 2 drug dose - DA
- Medical subject headings
- Elephantiasis, Filarial, Scabies, Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 drug dose - IDADrug
Also called IDA
Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Participants excluded from ivermectin will receive a topical dose of permethrin cream.
Exclusion criteria for ivermectin, diethylcarbamazine and albendazole:
- severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
- allergy to ivermectin, diethylcarbamazine or albendazole;
- pregnant;
- breastfeeding within 7 days of delivery;
- less than 2 years old; OR
- less than 15 kg
In addition if less than 5 years old excluded from ivermectin.
Exclusion criteria for permethrin:
- allergy to permethrin
- crusted scabies
3 drug dose - IDA with second dose of ivermectinDrug
Also called IDA with second dose of ivermectin
Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Eight days after treatment participants will be given a second dose of ivermectin alone.
Participants excluded from ivermectin will receive a topical dose of permethrin cream both on day 0 and day 8.
Exclusion criteria for ivermectin, diethylcarbamazine and albendazole:
- severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
- allergy to ivermectin, diethylcarbamazine or albendazole;
- pregnant;
- breastfeeding within 7 days of delivery;
- less than 2 years old; OR
- less than 15 kg
In addition if less than 5 years old excluded from ivermectin.
Exclusion criteria for permethrin:
- allergy to permethrin
- crusted scabies
2 drug dose - DADrug
Also called DA
Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine, and albendazole (DA).
If scabies is present in the participant or a household member permethrin cream will be provided 8 days after dose of DA.
Exclusion criteria for diethylcarbamazine and albendazole:
- severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
- allergy to diethylcarbamazine or albendazole;
- pregnant;
- breastfeeding within 7 days of delivery;
- less than 2 years old; OR
- less than 15 kg
Exclusion criteria for permethrin:
- allergy to permethrin
- crusted scabies
| Study group | Role | What they receive |
|---|---|---|
| IDA 1 | Experimental | * ivermectin, diethylcarbamazine and albendazole Day 0,
* permethrin Day 0 if excluded from ivermectin
Details of dosing:
* ivermectin: 200 mcg/kg oral
* diethylcarbazine: 6mg/kg oral
* albendazole 400mg oral
* permethrin 5% cream topical: apply to whole body and wash o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older. Receives: Drug: 3 drug dose - IDA |
| IDA 2 | Experimental | * ivermectin, diethylcarbamazine and albendazole Day 0, ivermectin Day 8
* permethrin Day 0 and Day 8 if excluded from ivermectin
Details of dosing:
* ivermectin: 200 mcg/kg oral
* diethylcarbazine: 6mg/kg oral
* albendazole 400mg oral
* permethrin 5% cream topical: apply to whole body and wash o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older. Receives: Drug: 3 drug dose - IDA with second dose of ivermectin |
| DA | Active comparator | * diethylcarbamazine and albendazole Day 0
* permethrin Day 8 if scabies present in participant or household member
Details of dosing:
* diethylcarbazine: 6mg/kg oral
* albendazole 400mg oral
* permethrin 5% cream topical: apply to whole body and wash off after 4hrs when less than 2 months; apply to whole body and wash o after 8hrs when 2 months and older. Receives: Drug: 2 drug dose - DA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
Participants will be interviewed and asked to report their general health status at baseline before receiving treatment and daily for the 2 days following treatment (Active Adverse Event Monitoring phase). For 3 to 7 days following treatment, anyone unwell the preceding day will be actively followed, other participants will be interviewed only if they feel unwell and present to the study team (Passive Adverse Event Monitoring phase).
At any stage if they describe being unwell, further questions to determine type and severity of symptom(s) experienced will be asked and recorded according to pre-defined adverse event table. If participants report moderate to severe symptoms they will have further medical assessments as required.
LF infection status will be determined by Filiarial Test Strip (FTS) and microfilariae (mf) smears.
Measured: within 7 days of drug administration
Secondary outcomes (5)
Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
Methods of assessment: FTS and Dried Blood Spot (DBS) for filarial antigenemia, mf smears for microfilariae
Measured: Baseline and 12 months
Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Methods of assessment: Skin examination
Measured: Baseline and 12 months
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
Methods of assessment: Stool samples will be analysed using Kato-katz method, as well as PCR.
Measured: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
Methods of assessment: Acceptability Survey, designed specifically for the Triple therapy studies, Focus group discussions, Interviews with key informants
Measured: Approximately 4 weeks following treatment
Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Methods of assessment: Skin examination
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start13 Jul 2017
- Primary completion22 Nov 2017
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Task Force for Global Health, Murdoch Childrens Research Institute
- Responsible party
- Sponsor
- Investigators
- Andrew Steer, PhD, Principal investigator, Murdoch Childrens Research InstituteGary Weil, MD, Principal investigator, Washington University School of MedicineChristopher King, MD PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177993
- Sponsor's protocol ID
- 201607068-2
- Acronym
- FIT
- Status last verified
- Dec 2020
- First submitted
- 31 May 2017
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
Publications
Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Schuster T, Grobler AC, Engelman D, Robinson LJ, Kaldor JM, Steer AC. Community control strategies for scabies: A cluster randomised noninferiority trial. PLoS Med. 2021 Nov 10;18(11):e1003849. doi: 10.1371/journal.pmed.1003849. eCollection 2021 Nov.
PubMed 34758017Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Grobler AC, Robinson LJ, Kaldor JM, Steer AC. Individual Efficacy and Community Impact of Ivermectin, Diethylcarbamazine, and Albendazole Mass Drug Administration for Lymphatic Filariasis Control in Fiji: A Cluster Randomized Trial. Clin Infect Dis. 2021 Sep 15;73(6):994-1002. doi: 10.1093/cid/ciab202.
PubMed 33728462
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) Versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
- ClinicalTrials.gov ID
- NCT03177993
- Acronym / sponsor ID
- FIT / 201607068-2
- Conditions
- Lymphatic Filariases, Scabies, Impetigo, Soil Transmitted Helminths
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,773 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Task Force for Global Health, Murdoch Childrens Research Institute
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required.
In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy.
Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomized study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed.
In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IDA 1 | Experimental | Drug: 3 drug dose - IDA* ivermectin, diethylcarbamazine and albendazole Day 0, * permethrin Day 0 if excluded from ivermectin Details of dosing: * ivermectin: 200 mcg/kg oral * diethylcarbazine: 6mg/kg oral * albendazole 400mg oral * permethrin 5% cream topical: apply to whole body and wash o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older. |
| IDA 2 | Experimental | Drug: 3 drug dose - IDA with second dose of ivermectin* ivermectin, diethylcarbamazine and albendazole Day 0, ivermectin Day 8 * permethrin Day 0 and Day 8 if excluded from ivermectin Details of dosing: * ivermectin: 200 mcg/kg oral * diethylcarbazine: 6mg/kg oral * albendazole 400mg oral * permethrin 5% cream topical: apply to whole body and wash o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older. |
| DA | Active comparator | Drug: 2 drug dose - DA* diethylcarbamazine and albendazole Day 0 * permethrin Day 8 if scabies present in participant or household member Details of dosing: * diethylcarbazine: 6mg/kg oral * albendazole 400mg oral * permethrin 5% cream topical: apply to whole body and wash off after 4hrs when less than 2 months; apply to whole body and wash o after 8hrs when 2 months and older. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All community members that have given written informed consent to participate
Key exclusion criteria (1 listed)
- No informed consent
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 |
|---|---|---|
| 3 drug dose - IDAAlso: IDALymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Participants excluded from ivermectin will receive a topical dose of permethrin cream. Exclusion criteria for ivermectin, diethylcarbamazine and albendazole: * severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living); * allergy to ivermectin, diethylcarbamazine or albendazole; * pregnant; * breastfeeding within 7 days of delivery; * less than 2 years old; OR * less than 15 kg In addition if less than 5 years old excluded from ivermectin. Exclusion criteria for permethrin: * allergy to permethrin * crusted scabies | Drug | IDA 1 |
| 3 drug dose - IDA with second dose of ivermectinAlso: IDA with second dose of ivermectinLymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Eight days after treatment participants will be given a second dose of ivermectin alone. Participants excluded from ivermectin will receive a topical dose of permethrin cream both on day 0 and day 8. Exclusion criteria for ivermectin, diethylcarbamazine and albendazole: * severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living); * allergy to ivermectin, diethylcarbamazine or albendazole; * pregnant; * breastfeeding within 7 days of delivery; * less than 2 years old; OR * less than 15 kg In addition if less than 5 years old excluded from ivermectin. Exclusion criteria for permethrin: * allergy to permethrin * crusted scabies | Drug | IDA 2 |
| 2 drug dose - DAAlso: DALymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine, and albendazole (DA). If scabies is present in the participant or a household member permethrin cream will be provided 8 days after dose of DA. Exclusion criteria for diethylcarbamazine and albendazole: * severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living); * allergy to diethylcarbamazine or albendazole; * pregnant; * breastfeeding within 7 days of delivery; * less than 2 years old; OR * less than 15 kg Exclusion criteria for permethrin: * allergy to permethrin * crusted scabies | Drug | DA |
Primary outcome
Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
Time frame: within 7 days of drug administration
Participants will be interviewed and asked to report their general health status at baseline before receiving treatment and daily for the 2 days following treatment (Active Adverse Event Monitoring phase). For 3 to 7 days following treatment, anyone unwell the preceding day will be actively followed, other participants will be interviewed only if they feel unwell and present to the study team (Passive Adverse Event Monitoring phase). At any stage if they describe being unwell, further questions to determine type and severity of symptom(s) experienced will be asked and recorded according to pre-defined adverse event table. If participants report moderate to severe symptoms they will have further medical assessments as required. LF infection status will be determined by Filiarial Test Strip (FTS) and microfilariae (mf) smears.
5 secondary outcomes
Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
Time frame: Baseline and 12 months
Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Time frame: Baseline and 12 months
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
Time frame: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
Time frame: Approximately 4 weeks following treatment
Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Time frame: Baseline and 12 months
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 31 Dec 2020.
- Derived from this study: PubMed 34758017Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Schuster T, Grobler AC, Engelman D, Robinson LJ, Kaldor JM, Steer AC. Community control strategies for scabies: A cluster randomised noninferiority trial. PLoS Med. 2021 Nov 10;18(11):e1003849. doi: 10.1371/journal.pmed.1003849. eCollection 2021 Nov.
- Derived from this study: PubMed 33728462Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Grobler AC, Robinson LJ, Kaldor JM, Steer AC. Individual Efficacy and Community Impact of Ivermectin, Diethylcarbamazine, and Albendazole Mass Drug Administration for Lymphatic Filariasis Control in Fiji: A Cluster Randomized Trial. Clin Infect Dis. 2021 Sep 15;73(6):994-1002. doi: 10.1093/cid/ciab202.
- Individual participant dataSharing planned: Yes. Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
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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.
Andrew Steer, PhD principal investigator
Murdoch Childrens Research Institute
Gary Weil, MD principal investigator
Washington University School of Medicine
Christopher King, MD PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 drug dose - IDA, 3 drug dose - IDA with second dose of ivermectin and 2 drug dose - DA in people with Lymphatic Filariases and Scabies, run by Washington University School of Medicine at 1 site in Fiji.
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 1 inclusion and 1 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 31 Dec 2020. 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 Fiji. 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.
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?
Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03 (time frame: within 7 days of drug administration). 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 NCT03177993, which also lists 2 linked publications.
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 31 Dec 2020.