InfectionsPCRAGANCT01742026
Aspergillus PCR Early Detection in High Risk Oncohematological Patients
An observational study of Infections, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular at 13 sites in Spain.
Trial summary
ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Aspergillus PCR technique and Aspergillus AGA technique
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- 13 sitesSpain
- Study dates
- Feb 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of hematological patients at high risk of invasive fungal infection. Like: Leukemia acute mieloblasticas, myelodysplastic syndrome, patients with intensive chemotherapy and allogeneic hematopoietic transplantation.
Who may be able to join
- Signature of informed consent to participate in the study.
- Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease.
- The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section.
Who cannot join
- Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation).
- Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively.
- Background of IFI proven / probable prior
- Probable IFI / tested at the time of inclusion in the study.
- Exclusion will cause a lack of compliance with the inclusion criteria.
- Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Complejo Hospitalario de A Coruña
A Coruña, 15006
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Vall d´Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Josep Trueta
Girona, 17007
Hospital Ramon y Cajal
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital morales Meseguer
Murcia, 30008
Hospital Central de Asturias
Oviedo, 33006
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Virgen del Rocio
Seville, 41013
Hospital Clinico de Valencia
Valencia, 46010
Hospital Clinico Lozano Blesa
Zaragoza, 50009
About this study
Official title: ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION
Read the detailed description
ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
- Conditions
- Infections
- Being tested
- Aspergillus PCR technique, Aspergillus AGA technique
- Keywords
- High risk aspergillosis infection patients
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspergillus PCR techniqueProcedure or surgery
Aspergillus DNA PCR technique
Aspergillus AGA techniqueProcedure or surgery
Aspergillus AGA technique
| Study group | Role | What they receive |
|---|---|---|
| High Risk Oncohematological Patients | Detection Aspergillus PCR technique and Aspergillus AGA technique Receives: Procedure: Aspergillus PCR technique; Procedure: Aspergillus AGA technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum
To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.
Measured: 18-20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionDec 2012
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 InfectionsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lourdes Vazquez, MD, Principal investigator, University of SalamancaIsabel Ruiz, Md, Principal investigator, Hospital Vall d´HebronRocio Parody, MD, Principal investigator, Hospital Virgen del RocioJavier Lopez, MD, Principal investigator, Hospital Ramon y CajalMontserrat Rovira, MD, Principal investigator, Hospital Clinic of BarcelonaMontserrat Batlle, MD, Principal investigator, Germans Trias i Pujol HospitalCarlos Vallejo, MD, Principal investigator, Hospital Central de AsturiasRosario Varela, MD, Principal investigator, Hospital de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742026
- Sponsor's protocol ID
- GETH-PCRAGA
- Acronym
- PCRAGA
- Status last verified
- Mar 2022
- First submitted
- 30 Oct 2012
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Aguado JM, Vazquez L, Fernandez-Ruiz M, Villaescusa T, Ruiz-Camps I, Barba P, Silva JT, Batlle M, Solano C, Gallardo D, Heras I, Polo M, Varela R, Vallejo C, Olave T, Lopez-Jimenez J, Rovira M, Parody R, Cuenca-Estrella M; PCRAGA Study Group; Spanish Stem Cell Transplantation Group; Study Group of Medical Mycology of the Spanish Society of Clinical Microbiology and Infectious Diseases; Spanish Network for Research in Infectious Diseases. Serum galactomannan versus a combination of galactomannan and polymerase chain reaction-based Aspergillus DNA detection for early therapy of invasive aspergillosis in high-risk hematological patients: a randomized controlled trial. Clin Infect Dis. 2015 Feb 1;60(3):405-14. doi: 10.1093/cid/ciu833. Epub 2014 Oct 21.
PubMed 25336623
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
- ClinicalTrials.gov ID
- NCT01742026
- Acronym / sponsor ID
- PCRAGA / GETH-PCRAGA
- Conditions
- Infections
- Keywords
- High risk aspergillosis infection patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celularUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 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.
ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION
Detailed description
ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Oncohematological Patients | – | Procedure: Aspergillus PCR technique, Procedure: Aspergillus AGA techniqueDetection Aspergillus PCR technique and Aspergillus AGA technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of hematological patients at high risk of invasive fungal infection. Like: Leukemia acute mieloblasticas, myelodysplastic syndrome, patients with intensive chemotherapy and allogeneic hematopoietic transplantation.
Key inclusion criteria (3 listed)
- Signature of informed consent to participate in the study.
- Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease.
- The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section.
Key exclusion criteria (6 listed)
- Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation).
- Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively.
- Background of IFI proven / probable prior
- Probable IFI / tested at the time of inclusion in the study.
- Exclusion will cause a lack of compliance with the inclusion criteria.
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 |
|---|---|---|
| Aspergillus PCR techniqueAspergillus DNA PCR technique | Procedure or surgery | High Risk Oncohematological Patients |
| Aspergillus AGA techniqueAspergillus AGA technique | Procedure or surgery | High Risk Oncohematological Patients |
Primary outcome
Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum
Time frame: 18-20 months
To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.
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 Mar 2022.
- Derived from this study: PubMed 25336623Aguado JM, Vazquez L, Fernandez-Ruiz M, Villaescusa T, Ruiz-Camps I, Barba P, Silva JT, Batlle M, Solano C, Gallardo D, Heras I, Polo M, Varela R, Vallejo C, Olave T, Lopez-Jimenez J, Rovira M, Parody R, Cuenca-Estrella M; PCRAGA Study Group; Spanish Stem Cell Transplantation Group; Study Group of Medical Mycology of the Spanish Society of Clinical Microbiology and Infectious Diseases; Spanish Network for Research in Infectious Diseases. Serum galactomannan versus a combination of galactomannan and polymerase chain reaction-based Aspergillus DNA detection for early therapy of invasive aspergillosis in high-risk hematological patients: a randomized controlled trial. Clin Infect Dis. 2015 Feb 1;60(3):405-14. doi: 10.1093/cid/ciu833. Epub 2014 Oct 21.
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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.
Lourdes Vazquez, MD principal investigator
University of Salamanca
Isabel Ruiz, Md principal investigator
Hospital Vall d´Hebron
Rocio Parody, MD principal investigator
Hospital Virgen del Rocio
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular at 13 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 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
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?
Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum (time frame: 18-20 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 NCT01742026, 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 31 Mar 2022.