Gram-Negative InfectionsPhase 4NCT04895657
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
A Phase 4 study testing Piperacillin/Tazobactam Continuous infusion and Piperacillin/Tazobactam Intermittent infusion in people with Gram-Negative Infections, run by Ain Shams University at 1 site in Egypt.
Trial summary
Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Gram-Negative Infections
- What is being tested?
- Piperacillin/Tazobactam Continuous infusion and Piperacillin/Tazobactam Intermittent infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2018to 26 Jan 2020
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-74 years
- Expected ICU stay more than 24 hours
Who cannot join
- Allergy or potential allergy to the study medications
- Pregnancy
- Patients with CrCl< 20 ml/min or on dialysis
- Cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.
Read the detailed description
A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications
- Patient evaluation and assessment:
The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :
- Kidney functions (Serum creatinine, blood urea nitrogen)
- Liver functions (ALT, AST, Bil D, Bil T, Albumin)
- Complete blood count
- Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
- Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
- APACHE II Variables
- Conditions
- Gram-Negative Infections
- Being tested
- Piperacillin/Tazobactam Continuous infusion, Piperacillin/Tazobactam Intermittent infusion
- Keywords
- Antibiotics, Beta-lactams, Continuous administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/Tazobactam Continuous infusionDrug
Also called Piprataz injection
Continuous infusion
Piperacillin/Tazobactam Intermittent infusionDrug
Also called Piprataz injection
Intermittent infusion
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin/Tazobactam Intermittent infusion | Other | 4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours. Receives: Drug: Piperacillin/Tazobactam Intermittent infusion |
| Piperacillin/Tazobactam Continuous infusion | Other | 4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours. Receives: Drug: Piperacillin/Tazobactam Continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Clinical cure, expressed in percentage, will be considered fulfilled if all the following criteria are met : Cure or improvement of clinical signs and symptoms caused by the infection, normalized WBCs and body temperature.
Measured: ICU length of stay, assessed up to 30 days
Total cost
Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )
Measured: ICU length of stay, assessed up to 30 days
Secondary outcomes (4)
ICU Length of stay
ICU Length of stay in Days
Measured: ICU length of stay, assessed up to 30 days
Mortality
percentage
Measured: ICU length of stay, assessed up to 30 days
Readmission within 30- days
Days
Measured: 30 days
Adverse drug events
Any adverse event occurring during study drug administration
Measured: ICU length of stay, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start27 Jul 2018
- Primary completion26 Jan 2020
- Study completion26 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Negative InfectionsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Medhat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895657
- Sponsor's protocol ID
- 198
- Status last verified
- May 2021
- First submitted
- 19 Apr 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
- ClinicalTrials.gov ID
- NCT04895657
- Acronym / sponsor ID
- 198
- Conditions
- Gram-Negative Infections
- Keywords
- Antibiotics, Beta-lactams, Continuous administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Jan 2020 (actual)
- First posted
- 20 May 2021 (actual)
- 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.
Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.
Detailed description
A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications
- Patient evaluation and assessment:
The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :
- Kidney functions (Serum creatinine, blood urea nitrogen)
- Liver functions (ALT, AST, Bil D, Bil T, Albumin)
- Complete blood count
- Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
- Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
- APACHE II Variables
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/Tazobactam Intermittent infusion | Other | Drug: Piperacillin/Tazobactam Intermittent infusion4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours. |
| Piperacillin/Tazobactam Continuous infusion | Other | Drug: Piperacillin/Tazobactam Continuous infusion4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-74 years
- Expected ICU stay more than 24 hours
Key exclusion criteria (4 listed)
- Allergy or potential allergy to the study medications
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 |
|---|---|---|
| Piperacillin/Tazobactam Continuous infusionAlso: Piprataz injectionContinuous infusion | Drug | Piperacillin/Tazobactam Continuous infusion |
| Piperacillin/Tazobactam Intermittent infusionAlso: Piprataz injectionIntermittent infusion | Drug | Piperacillin/Tazobactam Intermittent infusion |
Primary outcome
Clinical cure
Time frame: ICU length of stay, assessed up to 30 days
Clinical cure, expressed in percentage, will be considered fulfilled if all the following criteria are met : Cure or improvement of clinical signs and symptoms caused by the infection, normalized WBCs and body temperature.
Total cost
Time frame: ICU length of stay, assessed up to 30 days
Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )
4 secondary outcomes
ICU Length of stay
Time frame: ICU length of stay, assessed up to 30 days
Mortality
Time frame: ICU length of stay, assessed up to 30 days
Readmission within 30- days
Time frame: 30 days
Adverse drug events
Time frame: ICU length of stay, assessed up to 30 days
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 20 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Piperacillin/Tazobactam Continuous infusion and Piperacillin/Tazobactam Intermittent infusion in people with Gram-Negative Infections, run by Ain Shams University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 20 May 2021. 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 Egypt. 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?
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?
Clinical cure (time frame: ICU length of stay, assessed up to 30 days). The study lists 2 primary outcomes in all. 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 20 May 2021.