InfectionEGAST 2008NCT00728624
Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns
An observational study of Infection, run by Pfizer at 12 sites in India.
Trial summary
EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites). Objectives: Comparison of antimicrobial susceptibility using disc-diffusion method Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- How many people
- 2,039 participants
- Where
- 12 sitesIndia
- Study dates
- Nov 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Isolates from hospitalised patients
Who may be able to join
- Isolates (as specified in the observational plan) from hospitalised patients
Who cannot join
- Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded.
- Isolates identified as commensals or contaminants will be excluded
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 076
Pfizer Investigational Site
Bangalore, Karnataka, 560034
Pfizer Investigational Site
Chandigarh, Punjab, 160 012
Pfizer Investigational Site
Chennai, 600 006
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 082
Pfizer Investigational Site
Kolkata, West Bengal, 700 027
Pfizer Investigational Site
Kolkata, West Bengal, 700 029
Pfizer Investigational Site
Kolkata, West Bengal, 700 098
Pfizer Investigational Site
Manipal, Karnataka, 576 104
Pfizer Investigational Site
Mumbai, Maharashtra, 400 016
Pfizer Investigational Site
New Delhi, 110 029
Pfizer Investigational Site
Porur, Chennai, Tamil Nadu
About this study
Official title: Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method
EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites).
Objectives:
- Comparison of antimicrobial susceptibility using disc-diffusion method
- Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
Read the detailed description
n/a n/a
- Conditions
- Infection
- Keywords
- Antibiotic susceptibility; beta lactamase; ESBLs
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of antimicrobial susceptibility using disc-diffusion method
Measured: duration of trial
Secondary outcomes (1)
Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
Measured: duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728624
- Sponsor's protocol ID
- A1891005
- Acronym
- EGAST 2008
- Status last verified
- Mar 2017
- First submitted
- 4 Aug 2008
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method
- ClinicalTrials.gov ID
- NCT00728624
- Acronym / sponsor ID
- EGAST 2008 / A1891005
- Conditions
- Infection
- Keywords
- Antibiotic susceptibility; beta lactamase; ESBLs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,039 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Aug 2008 (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.
EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites).
Objectives:
- Comparison of antimicrobial susceptibility using disc-diffusion method
- Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
Detailed description
n/a n/a
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Isolates from hospitalised patients
Key inclusion criteria (1 listed)
- Isolates (as specified in the observational plan) from hospitalised patients
Key exclusion criteria (2 listed)
- Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded.
- Isolates identified as commensals or contaminants will be excluded
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
Comparison of antimicrobial susceptibility using disc-diffusion method
Time frame: duration of trial
1 secondary outcome
Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
Time frame: duration of trial
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 Mar 2017.
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Pfizer at 12 sites in India.
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 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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?
Comparison of antimicrobial susceptibility using disc-diffusion method (time frame: duration of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2017.