StrongyloidiasisPhase 3STRONGTREATNCT01570504
Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
A Phase 3 study testing Ivermectin in people with Strongyloidiasis, run by Centro per le Malattie Tropicali at 9 sites in 3 countries.
Trial summary
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Strongyloidiasis
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Mar 2013to 8 Jun 2018
- Phase
- Phase 3
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients older than 5 years and weighting > 15 kg
- Current residence in non-endemic areas
- Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at "high" titer, irrespective of results of direct tests
Who cannot join
- Pregnant or lactating women
- Subjects suffering from CNS diseases
- Disseminated strongyloidiasis
- Immunocompromised patients.
- Lack of informed consent
- Previous treatment with ivermectin (in the last year)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy4 sites
Clinica di Malattie Infettive e Tropicali
Brescia
UFDID, Azienda Ospedaliero-universitaria Careggi
Florence
Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
Florence
Centro per le Malattie Tropicali, Ospedale Sacro Cuore
Negrar, Verona, 37024
Spain3 sites
FCRB, Hospital Clinic de Barcelona
Barcelona
Unitat Medicina Tropical i Salut Internacional Drassanes
Barcelona
Unidad de Medicina, Hospital de Poniente-El Ejido
El Ejido, Almeria
United Kingdom2 sites
Addenbrookes Hospital, Cambridge University Hospital
Cambridge
UCLH
London
About this study
Official title: Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.
Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
- Conditions
- Strongyloidiasis
- Being tested
- Ivermectin
- Keywords
- Strongyloidiasis, Strongyloides stercoralis, Ivermectin
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Stromectol
oral formulation
| Study group | Role | What they receive |
|---|---|---|
| ivermectin multiple doses | Experimental | A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16 Receives: Drug: Ivermectin |
| 1 dose ivermectin | Active comparator | A single 200 mcg/kg dose of ivermectin Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance of strongyloides infection
Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff
Measured: 12 months
Secondary outcomes (7)
All-cause mortality during the 12 months of follow-up.
Measured: 12 months
Patients with partial response to treatment at T 2
Measured: 12 months
Patients with adverse reactions
grade 1 to 5 as defined in detailed protocol
Measured: From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
Patients with increase in blood ALT over cutoff value
Measured: Day 17
Patients with decrease in WBC count below cutoff value
Measured: Day 17
Average difference in blood ALT and WBC count at day 17, compared with baseline
Measured: Day 17
Average difference in blood eosinophil count at T2, compared with baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2013
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
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 StrongyloidiasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro per le Malattie Tropicali
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Zeno Bisoffi, MD, PhD, Principal investigator, Centre for Tropical Diseases, Negrar (Verona), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570504
- Sponsor's protocol ID
- CTD1-2012
- Other IDs
- 2011-002784-24
- Acronym
- STRONGTREAT
- Status last verified
- Jun 2018
- First submitted
- 27 Mar 2012
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Buonfrate D, Salas-Coronas J, Munoz J, Maruri BT, Rodari P, Castelli F, Zammarchi L, Bianchi L, Gobbi F, Cabezas-Fernandez T, Requena-Mendez A, Godbole G, Silva R, Romero M, Chiodini PL, Bisoffi Z. Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial. Lancet Infect Dis. 2019 Nov;19(11):1181-1190. doi: 10.1016/S1473-3099(19)30289-0. Epub 2019 Sep 23.
PubMed 31558376
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
- ClinicalTrials.gov ID
- NCT01570504
- Acronym / sponsor ID
- STRONGTREAT / CTD1-2012
- Conditions
- Strongyloidiasis
- Keywords
- Strongyloidiasis, Strongyloides stercoralis, Ivermectin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Centro per le Malattie TropicaliUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Mar 2013 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 4 Apr 2012 (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.
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.
Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ivermectin multiple doses | Experimental | Drug: IvermectinA dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16 |
| 1 dose ivermectin | Active comparator | Drug: IvermectinA single 200 mcg/kg dose of ivermectin |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients older than 5 years and weighting > 15 kg
- Current residence in non-endemic areas
- Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at "high" titer, irrespective of results of direct tests
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Subjects suffering from CNS diseases
- Disseminated strongyloidiasis
- Immunocompromised patients.
- Lack of 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 |
|---|---|---|
| IvermectinAlso: Stromectoloral formulation | Drug | 1 dose ivermectin, ivermectin multiple doses |
Primary outcome
clearance of strongyloides infection
Time frame: 12 months
Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff
7 secondary outcomes
All-cause mortality during the 12 months of follow-up.
Time frame: 12 months
Patients with partial response to treatment at T 2
Time frame: 12 months
Patients with adverse reactions
Time frame: From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
Patients with increase in blood ALT over cutoff value
Time frame: Day 17
Patients with decrease in WBC count below cutoff value
Time frame: Day 17
Average difference in blood ALT and WBC count at day 17, compared with baseline
Time frame: Day 17
Average difference in blood eosinophil count at T2, compared with baseline
Time frame: 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 14 Jun 2018.
- Derived from this study: PubMed 31558376Buonfrate D, Salas-Coronas J, Munoz J, Maruri BT, Rodari P, Castelli F, Zammarchi L, Bianchi L, Gobbi F, Cabezas-Fernandez T, Requena-Mendez A, Godbole G, Silva R, Romero M, Chiodini PL, Bisoffi Z. Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial. Lancet Infect Dis. 2019 Nov;19(11):1181-1190. doi: 10.1016/S1473-3099(19)30289-0. Epub 2019 Sep 23.
- Individual participant dataSharing planned: No
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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.
Zeno Bisoffi, MD, PhD principal investigator
Centre for Tropical Diseases, Negrar (Verona), Italy
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin in people with Strongyloidiasis, run by Centro per le Malattie Tropicali at 9 sites in 3 countries.
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 3 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 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Spain, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
clearance of strongyloides infection (time frame: 12 months). 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 NCT01570504, 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 14 Jun 2018.