Chagas DiseasePhase 2CHAGASAZOLNCT01162967
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
A Phase 2 study testing Benznidazole and Posaconazole in people with Chagas Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
Trial summary
The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Benznidazole and Posaconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesSpain
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients with serological evidence of Chagas infection and positive PCR real time
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Infectious Disease Department Vall d'Hebron Hospital
Barcelona
International Health Unit Drassanes
Barcelona
International Health Unit Metropolitana Nord
Santa Coloma, Barcelona
About this study
Official title: PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.
- Conditions
- Chagas Disease
- Being tested
- Benznidazole, Posaconazole
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenznidazoleDrug
Standard dosage
PosaconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Benznidazole | Active comparator | Not described Receives: Drug: Benznidazole |
| Posaconazole, low dose | Experimental | Not described Receives: Drug: Posaconazole |
| Posaconazole, high dose | Experimental | Not described Receives: Drug: Posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasitological cure measured by a real time PCR in blood sample
PCR negative at the end of follow up
Measured: 12 months after starting treatment
Secondary outcomes (2)
Parasitological cure measured by real time PCR in blood sample
substained parasitological response
Measured: End of treatment, weeks 8, 16, 24 and 40 after treatment
Safety and tolerability of both drugs
Measured: First 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionMar 2013
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 Chagas DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Tropical Medicine and International Health Unit Drassanes. Barcelona, International Health Unit Metropolitana Nord. Santa Coloma.
- Responsible party
- Sponsor
- Investigators
- Molina Israel, MD, Principal investigator, Infectious Disease Department Vall d'Hebron HospitalPahisssa Albert, MD Ph, Study chair, Infectious Disease Department Vall d'Hebron HospitalGomez Jordi, MD, Principal investigator, International Health Unit DrassanesValerio Lluis, MD, Principal investigator, International Health Unit Metropolitana Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162967
- Sponsor's protocol ID
- CHAGASAZOL01
- Acronym
- CHAGASAZOL
- Status last verified
- Sep 2013
- First submitted
- 20 May 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122.
PubMed 24827034
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
- ClinicalTrials.gov ID
- NCT01162967
- Acronym / sponsor ID
- CHAGASAZOL / CHAGASAZOL01
- Conditions
- Chagas Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Tropical Medicine and International Health Unit Drassanes. Barcelona, International Health Unit Metropolitana Nord. Santa Coloma.
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Jul 2010 (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.
The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benznidazole | Active comparator | Drug: Benznidazole |
| Posaconazole, low dose | Experimental | Drug: Posaconazole |
| Posaconazole, high dose | Experimental | Drug: Posaconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients with serological evidence of Chagas infection and positive PCR real time
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BenznidazoleStandard dosage | Drug | Benznidazole |
| Posaconazole | Drug | Posaconazole, high dose, Posaconazole, low dose |
Primary outcome
Parasitological cure measured by a real time PCR in blood sample
Time frame: 12 months after starting treatment
PCR negative at the end of follow up
2 secondary outcomes
Parasitological cure measured by real time PCR in blood sample
Time frame: End of treatment, weeks 8, 16, 24 and 40 after treatment
Safety and tolerability of both drugs
Time frame: First 2 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 10 Sep 2013.
- Derived from this study: PubMed 24827034Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122.
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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.
Molina Israel, MD principal investigator
Infectious Disease Department Vall d'Hebron Hospital
Pahisssa Albert, MD Ph study chair
Infectious Disease Department Vall d'Hebron Hospital
Gomez Jordi, MD principal investigator
International Health Unit Drassanes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benznidazole and Posaconazole in people with Chagas Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
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 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Parasitological cure measured by a real time PCR in blood sample (time frame: 12 months after starting treatment). 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 NCT01162967, 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 10 Sep 2013.