Clinical ResponseCRABNCT07671755
Colistin Versus Colistin Combined With Cefoperazone-sulbactam for Multiresistant Acinetobactor Baumannii Ventilator-associated Pneumonia Treatment
A study testing colistin plus cefoperazone-sulbactam combination group and Colistin in people with Clinical Response and Radiological Response, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
This study aims to evaluate clinical outcomes of colistin versus colistin in combination with cefoperazone-sulbactam for patients with MDR-AB VAP treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clinical Response, Radiological Response
- What is being tested?
- colistin plus cefoperazone-sulbactam combination group and Colistin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of VAP due to A. baumannii
Who cannot join
- patients who had polymicrobial VAP
- Patients with pre-existing severe renal failure and/or abnormal liver function tests
- Patients allergic to colistin or cefoperazone-sulbactam
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate clinical outcomes of colistin versus colistin in combination with cefoperazone-sulbactam for patients with MDR-AB VAP treatment.
Read the detailed description
MDR-AB (multidrug-resistant Acinetobacter baumannii) has been an increasingly common cause of ventilator-associated pneumonia (VAP) in intensive care unit (ICU). Colistin remains the last available antibiotic choice. Unfortunately, colistin monotherapy is often inadequate for microbiologic eradication and a risk factor of nephrotoxicity and for heteroresistance.
- Conditions
- Clinical Response, Radiological Response
- Being tested
- colistin plus cefoperazone-sulbactam combination group, Colistin
- Keywords
- multidrug-resistant Acinetobacter baumannii, ventilator-associated pneumonia, intensive care unit
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colistin plus cefoperazone-sulbactam combination groupDrug
Combination therapy
ColistinDrug
Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group received colistin plus cefoperazone-sulbactam combination group. Receives: Drug: colistin plus cefoperazone-sulbactam combination group |
| Comparator | Active comparator | Comparator group received colistin monotherapy Receives: Drug: Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Clinical response was defined as observable improvement in the patient's clinical signs/symptoms, including absence of fever (temp<38ºC) for three consecutive days or more, and decreasing amount and purulence of tracheal secretions
Measured: within one week
Secondary outcomes (1)
Radiological response
Radiological response was defined as improvement/resolution of pulmonary infiltrates, as noted on chest x-rays following treatment.
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Feb 2025
- Primary completion30 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical ResponseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renuka Kahuja, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671755
- Sponsor's protocol ID
- IRB-000154/SMBBIT/Approval/202
- Acronym
- CRAB
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistin Versus Colistin Combined With Cefoperazone-sulbactam for Multiresistant Acinetobactor Baumannii Ventilator-associated Pneumonia Treatment
- ClinicalTrials.gov ID
- NCT07671755
- Acronym / sponsor ID
- CRAB / IRB-000154/SMBBIT/Approval/202
- Conditions
- Clinical Response, Radiological Response
- Keywords
- multidrug-resistant Acinetobacter baumannii, ventilator-associated pneumonia, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Jun 2026 (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.
This study aims to evaluate clinical outcomes of colistin versus colistin in combination with cefoperazone-sulbactam for patients with MDR-AB VAP treatment.
Detailed description
MDR-AB (multidrug-resistant Acinetobacter baumannii) has been an increasingly common cause of ventilator-associated pneumonia (VAP) in intensive care unit (ICU). Colistin remains the last available antibiotic choice. Unfortunately, colistin monotherapy is often inadequate for microbiologic eradication and a risk factor of nephrotoxicity and for heteroresistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: colistin plus cefoperazone-sulbactam combination groupIntervention group received colistin plus cefoperazone-sulbactam combination group. |
| Comparator | Active comparator | Drug: ColistinComparator group received colistin monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of VAP due to A. baumannii
Key exclusion criteria (3 listed)
- patients who had polymicrobial VAP
- Patients with pre-existing severe renal failure and/or abnormal liver function tests
- Patients allergic to colistin or cefoperazone-sulbactam
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 |
|---|---|---|
| colistin plus cefoperazone-sulbactam combination groupCombination therapy | Drug | Intervention |
| ColistinMonotherapy | Drug | Comparator |
Primary outcome
Clinical response
Time frame: within one week
Clinical response was defined as observable improvement in the patient's clinical signs/symptoms, including absence of fever (temp<38ºC) for three consecutive days or more, and decreasing amount and purulence of tracheal secretions
1 secondary outcome
Radiological response
Time frame: within one week
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 26 Jun 2026.
- Colistin versus Colistin Combined with Ampicillin-Sulbactam for Multiresistant Acinetobacter baumannii Ventilator-associated Pneumonia Treatment: An Open-label Prospective StudyLink provided by the sponsor.
- Comparison of colistin and colistin/sulbactam for the treatment of multidrug resistant Acinetobacter baumannii ventilator-associated pneumoniaLink provided by the sponsor.
- 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 study testing colistin plus cefoperazone-sulbactam combination group and Colistin in people with Clinical Response and Radiological Response, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
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 3 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 26 Jun 2026. 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 Pakistan. 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?
Clinical response (time frame: within one week). 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 26 Jun 2026.