Urinary Tract Infection (cUTI)RECOMMENDNCT02364284
Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP
An observational study of Urinary Tract Infection (cUTI) and Intra-abdominal Infection (cIAI) and, run by Pfizer at 27 sites in 6 countries.
Trial summary
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
- How many people
- 1,322 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Feb 2015to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) patients. Hospitalized patients with a diagnosis of at least one of the following three conditions during the period July 1, 2013 to June 30, 2014 should be included in this study. Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP
Who may be able to join
- ICF to be obtained (refer slides 26-30) Adult (≥18 years) patients Patients with a diagnosis of at least one of the three conditions hospitalised during the period July 1, 2013 to June 30, 2014 Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP
Who cannot join
- The patient participated in a clinical trial during the patient selection period (01-Jul-2013 to 30-Jun-2014) or during the follow-up period For patients diagnosed with cUTI: The patient has a diagnosis of hospital acquired or healthcare associated cUTI with concomitant presence of Fungal UTI with colony count > 10^3/mL
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
France6 sites
Research Site
Argenteuil
Research Site
Bordeaux
Research Site
Créteil
Research Site
Limoges
Research Site
Lyon
Research Site
Nantes
Italy5 sites
Research Site
Bologna
Research Site
Brescia
Research Site
Monza
Research Site
Roma
Research Site
Vicenza
Spain5 sites
Research Site
Badalona
Research Site
Barcelona
Research Site
Oviedo
Research Site
Seville
Research Site
Terrassa
Greece4 sites
Research Site
Athens
Research Site
Heraklion
Research Site
Pátrai
Research Site
Thessaloniki
Russia4 sites
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Saint Petersburg
Research Site
Sestroretsk, Saint Petersburg
Brazil3 sites
Research Site
Belo Horizonte
Research Site
Campinas
Research Site
Porto Alegre
About this study
Official title: Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study
Read the detailed description
This will be an observational, historical cohort study from medical chart review of adult hospitalized patients for each of the three conditions of interest (complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP)). For this study, the proposed patient selection period extends for 12 months, from July 1, 2013 to June 30, 2014. Patients selected during this period will be followed from diagnosis (i.e., diagnosis of cUTI, cIAI or NP) until symptom resolution, discharge or 30-days post discharge [based on data availability to assess readmission and outpatient visits], death while hospitalized, loss to follow-up or the end of study period if not yet discharged from index hospitalization [December 31, 2014]).
- Conditions
- Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
- Medical subject headings
- Urinary Tract Infections, Intraabdominal Infections, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Tract Infection (cUTI) | Patients ≥18 years with diagnosis of urinary tract infection. | |
| Intra Abdominal Infection(cIAI) | Patients ≥ 18 years with diagnosis of Intra Abdominal Infection | |
| Nosocomial Pneumonia (NP) | Patients ≥ 18 years with diagnosis of Hospital acquired pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Evaluate failure or success of the initial antibiotic treatment following cUTI, cIAI and NP diagnosis. Initial antibiotic therapy is defined as all antibiotic agents received during the 48 hours post initiation of antibiotic therapy - The primary outcome measure will be assessed from the antibiotic initiation date until end of follow-up defined by in-hospital with symptom resolution, in-hospital without symptom resolution, discharged to home, discharged to other health care facility, readmission within 30 days for same infection, readmission within 30 days post discharge with other diagnosis, death during hospital stay, death post discharge within 30 days.
Measured: 12 months
Secondary outcomes (2)
To identify potential risk factors related to outcomes of initial antibiotic treatment of hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Assess risk factors related to the primary outcome measure. Covariates considered in the risk assessment will include: site characteristics, patient characteristics, secondary infections, prior medical history and comorbidity burden, hospitalization characteristics, pathogen characteristics, co-medications - The listed covariates will be assessed at baseline (i.e., at index hospitalization date), during the hospital stay and the 30-day period post discharge date.
Measured: 12 months
To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome
Assess health care utilization among patients with cUTI, cIAI and NP. Variables assessed to address this will include - hospital length of stay, ICU length of stay, number of surgical procedures, number of outpatient visits, days on antibiotic therapy, number of readmission during follow-up - The listed measures will be assessed during the hospital stay and during the 30-day period post discharge date.
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 posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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 Urinary Tract Infection (cUTI)Studies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Fedou, Principal investigator, CHU de Limoges - Hôpital Dupuytren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364284
- Sponsor's protocol ID
- D4280R00005
- Acronym
- RECOMMEND
- Status last verified
- Sep 2017
- First submitted
- 6 Feb 2015
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.
PubMed 29742471Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.
PubMed 29128389
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.
- ClinicalTrials.gov ID
- NCT02364284
- Acronym / sponsor ID
- RECOMMEND / D4280R00005
- Conditions
- Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,322 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Feb 2015 (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.
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study
Detailed description
This will be an observational, historical cohort study from medical chart review of adult hospitalized patients for each of the three conditions of interest (complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP)). For this study, the proposed patient selection period extends for 12 months, from July 1, 2013 to June 30, 2014. Patients selected during this period will be followed from diagnosis (i.e., diagnosis of cUTI, cIAI or NP) until symptom resolution, discharge or 30-days post discharge [based on data availability to assess readmission and outpatient visits], death while hospitalized, loss to follow-up or the end of study period if not yet discharged from index hospitalization [December 31, 2014]).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urinary Tract Infection (cUTI) | – | –Patients ≥18 years with diagnosis of urinary tract infection. |
| Intra Abdominal Infection(cIAI) | – | –Patients ≥ 18 years with diagnosis of Intra Abdominal Infection |
| Nosocomial Pneumonia (NP) | – | –Patients ≥ 18 years with diagnosis of Hospital acquired pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) patients. Hospitalized patients with a diagnosis of at least one of the following three conditions during the period July 1, 2013 to June 30, 2014 should be included in this study. Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP
Key inclusion criteria (1 listed)
- ICF to be obtained (refer slides 26-30) Adult (≥18 years) patients Patients with a diagnosis of at least one of the three conditions hospitalised during the period July 1, 2013 to June 30, 2014 Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP
Key exclusion criteria (1 listed)
- The patient participated in a clinical trial during the patient selection period (01-Jul-2013 to 30-Jun-2014) or during the follow-up period For patients diagnosed with cUTI: The patient has a diagnosis of hospital acquired or healthcare associated cUTI with concomitant presence of Fungal UTI with colony count > 10^3/mL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Time frame: 12 months
Evaluate failure or success of the initial antibiotic treatment following cUTI, cIAI and NP diagnosis. Initial antibiotic therapy is defined as all antibiotic agents received during the 48 hours post initiation of antibiotic therapy - The primary outcome measure will be assessed from the antibiotic initiation date until end of follow-up defined by in-hospital with symptom resolution, in-hospital without symptom resolution, discharged to home, discharged to other health care facility, readmission within 30 days for same infection, readmission within 30 days post discharge with other diagnosis, death during hospital stay, death post discharge within 30 days.
2 secondary outcomes
To identify potential risk factors related to outcomes of initial antibiotic treatment of hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Time frame: 12 months
To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome
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 5 Sep 2017.
- Derived from this study: PubMed 29742471Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.
- Derived from this study: PubMed 29128389Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.
- D4280R00005\_RECOMMEND\_CSR\_Synopsis\_17Nov2016(redacted)\_finalLink provided by the sponsor.
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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.
Anne-Laure Fedou principal investigator
CHU de Limoges - Hôpital Dupuytren
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection (cUTI) and Intra-abdominal Infection (cIAI) and, run by Pfizer at 27 sites in 6 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 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Italy, Spain, Greece, Russia and 1 more country. 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?
To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP (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 NCT02364284, 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 5 Sep 2017.