Drug SafetyPhase 4NCT01297842
Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
A Phase 4 study testing Ertapenem and Meropenem or Imipenem in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
Trial summary
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Safety
- What is being tested?
- Ertapenem and Meropenem or Imipenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- May 2011to Aug 2013
- Phase
- Phase 4
- 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
- Hospitalized patients aged >18 years with documented ESBL +ve GNB infection
- Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy
Who cannot join
- Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
- Have active P. aeruginosa co-infection
- Pregnancy or breast feeding
- Allergy to carbapenems
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok, 10700
Visanu Thamlikitkul, MD, 662-412-5994, sivth@mahidol.ac.th
Visanu Thamlikitkul, MD
About this study
Official title: An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.
Read the detailed description
Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.
- Conditions
- Drug Safety
- Being tested
- Ertapenem, Meropenem or Imipenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Also called Invanz
Ertapenem 1 gram per day for 7 to 14 days
Meropenem or ImipenemDrug
Also called Meronem, Tienam
Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Experimental | Ertapenem 1 gram per day for 7 to 14 days Receives: Drug: Ertapenem |
| Meropenem or Imipenem | Active comparator | Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days Receives: Drug: Meropenem or Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with cure or improvement
Cure Improvement Persistence Death from Infection
Measured: 14 days
Secondary outcomes (1)
Number of subjects with eradication of the causative bacteria
Eradication Persistence Superinfection
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013 (estimated)
- Study completionAug 2013 (estimated)
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 Drug SafetyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visanu Thamlikitkul, Mahidol University
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297842
- Sponsor's protocol ID
- SirirajCEU 54-001
- Status last verified
- Dec 2011
- First submitted
- 14 Feb 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rattanaumpawan P, Werarak P, Jitmuang A, Kiratisin P, Thamlikitkul V. Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial. BMC Infect Dis. 2017 Mar 1;17(1):183. doi: 10.1186/s12879-017-2284-1.
PubMed 28249572
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections
- ClinicalTrials.gov ID
- NCT01297842
- Acronym / sponsor ID
- SirirajCEU 54-001
- Conditions
- Drug Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 17 Feb 2011 (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.
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.
Detailed description
Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Experimental | Drug: ErtapenemErtapenem 1 gram per day for 7 to 14 days |
| Meropenem or Imipenem | Active comparator | Drug: Meropenem or ImipenemMeropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients aged >18 years with documented ESBL +ve GNB infection
- Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy
Key exclusion criteria (4 listed)
- Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
- Have active P. aeruginosa co-infection
- Pregnancy or breast feeding
- Allergy to carbapenems
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 |
|---|---|---|
| ErtapenemAlso: InvanzErtapenem 1 gram per day for 7 to 14 days | Drug | Ertapenem |
| Meropenem or ImipenemAlso: Meronem, TienamMeropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days | Drug | Meropenem or Imipenem |
Primary outcome
Number of subjects with cure or improvement
Time frame: 14 days
Cure Improvement Persistence Death from Infection
1 secondary outcome
Number of subjects with eradication of the causative bacteria
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
- Derived from this study: PubMed 28249572Rattanaumpawan P, Werarak P, Jitmuang A, Kiratisin P, Thamlikitkul V. Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial. BMC Infect Dis. 2017 Mar 1;17(1):183. doi: 10.1186/s12879-017-2284-1.
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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.
Visanu Thamlikitkul, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem and Meropenem or Imipenem in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Jan 2012. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Visanu Thamlikitkul, MD (6624125994, sivth@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with cure or improvement (time frame: 14 days). 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 NCT01297842, 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 2 Jan 2012.