Chagas DiseaseBIOMARCHANCT01755377
New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease
An observational study of Chagas Disease, run by Barcelona Centre for International Health Research at 1 site in Spain.
Trial summary
Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Benznidazole
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Jun 2016
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Migrants from Latin America visiting the Tropical Medicin Clinic
Who may be able to join
- Patients from endemic areas (Latin America)
- Older than 18 years old and younger than 50
- With serological confirmation of Chagas Disease infection with two different techniques
- Indeterminate or initial cardiac form
- No previously treated for Chagas Disease
Who cannot join
- Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Spain1 site
International Health Department, Hospital Clinic, Barcelona
Barcelona, Catalonia, 08036
About this study
Official title: Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases
Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
- Conditions
- Chagas Disease
- Being tested
- Benznidazole
- 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
| Study group | Role | What they receive |
|---|---|---|
| No Chagas Disease | Participants with no Chagas Disease will be evaluated as a Control Group | |
| Chagas Disease | Participants diagnosed with Chagas Disease will be followed-up as a Case Group Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for prognosis, early diagnosis and effectiveness of treatment.
- Conventional polymerase chain reaction of T. cruzi in blood
- Measurement of Brain natriuretic factor
- Measurement of Prothrombotic factors
- Measurement of antibodies against specific proteins of the trypomastigote of T. cruzi
- Investigation of the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression
Measured: 2 years
Secondary outcomes (1)
Cardiac function after antiparasitic treatment
- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2016
- Study completionJun 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Centre for International Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquim Gascón, PhD, Principal investigator, Barcelona Centre for International Health Research (CRESIB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755377
- Sponsor's protocol ID
- BIOMARCHA
- Acronym
- BIOMARCHA
- Status last verified
- Aug 2016
- First submitted
- 19 Dec 2012
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
PubMed 29351667
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases
- ClinicalTrials.gov ID
- NCT01755377
- Acronym / sponsor ID
- BIOMARCHA / BIOMARCHA
- Conditions
- Chagas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Barcelona Centre for International Health ResearchUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Dec 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.
Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Chagas Disease | – | –Participants with no Chagas Disease will be evaluated as a Control Group |
| Chagas Disease | – | Drug: BenznidazoleParticipants diagnosed with Chagas Disease will be followed-up as a Case Group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Migrants from Latin America visiting the Tropical Medicin Clinic
Key inclusion criteria (5 listed)
- Patients from endemic areas (Latin America)
- Older than 18 years old and younger than 50
- With serological confirmation of Chagas Disease infection with two different techniques
- Indeterminate or initial cardiac form
- No previously treated for Chagas Disease
Key exclusion criteria (2 listed)
- Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
- Pregnancy or lactation
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 |
|---|---|---|
| Benznidazole | Drug | Chagas Disease |
Primary outcome
Biomarkers for prognosis, early diagnosis and effectiveness of treatment.
Time frame: 2 years
* Conventional polymerase chain reaction of T. cruzi in blood * Measurement of Brain natriuretic factor * Measurement of Prothrombotic factors * Measurement of antibodies against specific proteins of the trypomastigote of T. cruzi * Investigation of the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression
1 secondary outcome
Cardiac function after antiparasitic treatment
Time frame: 2 years
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 22 Aug 2016.
- Derived from this study: PubMed 29351667Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
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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.
Joaquim Gascón, PhD principal investigator
Barcelona Centre for International Health Research (CRESIB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Disease, run by Barcelona Centre for International Health Research at 1 site 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 5 inclusion and 2 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 22 Aug 2016. 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 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.
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?
Biomarkers for prognosis, early diagnosis and effectiveness of treatment. (time frame: 2 years). 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 NCT01755377, 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 22 Aug 2016.