Ventilator Associated PneumoniaNCT03477292
7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia
A study testing Duration of antibiotic in people with Ventilator Associated Pneumonia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Duration of antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Mar 2018to 31 Dec 2024
- 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 who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years
Who cannot join
- VAP due to other organisms; (b) pregnancy; (c) endotracheal or tracheostomy tube aspirate demonstrating growth of drug sensitive Acinetobacter baumanii or an organism other than Acinetobacter baumanii; and, (c) failure to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Respiratory ICU, Department of Pulmonary Medicine, PGIMER
Chandigarh, Chandigarh, 160012
Respiratory ICU, Post Graduate Institue of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: A Study to Compare 7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia Due to Drug Resistant Acinetobacter Baumanii
There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.
Read the detailed description
Ventilator-associated pneumonia (VAP) is one of the major causes of morbidity and mortality in the ICU, accounting for 25% of the total infections occurring in this setting and 50% of all antibiotic prescriptions in patients who are mechanically ventilated.1,2 The incidence of VAP depends not only on the type of the institution, the preventive measures and therapeutic approaches that are used, but also on the type of surveillance systems by which incidence is estimated. There are reports of incidence across different settings varying from 1.4 up to 42.8 episodes of VAP/1,000 ventilation-days.2 Patients with VAP have significantly longer ICU and hospital lengths of stay compared with similar patients without VAP.3,4 Consequently, the economic burden of VAP is considerable, leading to significant draining of resources. Even after adjusting for underlying severity of illness, the attributable cost of VAP amounts to several thousands of US dollars per patient.5 There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found.9 There was an increase in the antibiotic free days in the short course antibiotic arm. There was no difference in the number of relapses of VAP with either modality of treatment.9 In another analysis of six studies with 1088 subjects, there was a higher occurrence of relapses of VAP due to non-lactose fermenting gram negative organism.10 However, there was no difference in the mortality rates.10 The problem with both these meta-analyses was that they did not provide information regarding the outcomes of VAP due to Acinetobacter baumanii.9,10 Also, the short duration strategy included studies that randomized patients to seven to eight days and ten-to fifteen days in the long duration strategy. None of the previous studies has provided information about outcomes of VAP due to Acinetobacter baumanii. In our observation, most of the episodes of VAP in our ICU are due to drug resistant Acinetobacter baumanii. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Duration of antibiotic
- 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.
Duration of antibioticDrug
Also called Colisitin
Duration of antibiotic for treatment of VAP
| Study group | Role | What they receive |
|---|---|---|
| Long duration of antibiotics | Experimental | 14 days of Colistin Receives: Drug: Duration of antibiotic |
| Short duration of antibiotics | Active comparator | 7 days of Colistin Receives: Drug: Duration of antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapses of VAP
defined as repetitive clinically and microbiologically documented VAP due to the same pathogen
Measured: 28 days
Secondary outcomes (4)
Duration of mechanical ventilation
(non-invasive and invasive)
Measured: 28 days
ICU and hospital length of stay
Days spent in ICU and hospital
Measured: 90 days
28-day mortality
ICU or hospital mortality
Measured: 28 days
Antibiotic free days
Number of days spent without antibiotics
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Mar 2018
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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
- Model description
- Randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477292
- Sponsor's protocol ID
- IEC/82
- Status last verified
- Nov 2025
- First submitted
- 20 Mar 2018
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymized individual patient information and clinical details will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare 7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia Due to Drug Resistant Acinetobacter Baumanii
- ClinicalTrials.gov ID
- NCT03477292
- Acronym / sponsor ID
- IEC/82
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Mar 2018 (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.
There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.
Detailed description
Ventilator-associated pneumonia (VAP) is one of the major causes of morbidity and mortality in the ICU, accounting for 25% of the total infections occurring in this setting and 50% of all antibiotic prescriptions in patients who are mechanically ventilated.1,2 The incidence of VAP depends not only on the type of the institution, the preventive measures and therapeutic approaches that are used, but also on the type of surveillance systems by which incidence is estimated. There are reports of incidence across different settings varying from 1.4 up to 42.8 episodes of VAP/1,000 ventilation-days.2 Patients with VAP have significantly longer ICU and hospital lengths of stay compared with similar patients without VAP.3,4 Consequently, the economic burden of VAP is considerable, leading to significant draining of resources. Even after adjusting for underlying severity of illness, the attributable cost of VAP amounts to several thousands of US dollars per patient.5 There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found.9 There was an increase in the antibiotic free days in the short course antibiotic arm. There was no difference in the number of relapses of VAP with either modality of treatment.9 In another analysis of six studies with 1088 subjects, there was a higher occurrence of relapses of VAP due to non-lactose fermenting gram negative organism.10 However, there was no difference in the mortality rates.10 The problem with both these meta-analyses was that they did not provide information regarding the outcomes of VAP due to Acinetobacter baumanii.9,10 Also, the short duration strategy included studies that randomized patients to seven to eight days and ten-to fifteen days in the long duration strategy. None of the previous studies has provided information about outcomes of VAP due to Acinetobacter baumanii. In our observation, most of the episodes of VAP in our ICU are due to drug resistant Acinetobacter baumanii. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Long duration of antibiotics | Experimental | Drug: Duration of antibiotic14 days of Colistin |
| Short duration of antibiotics | Active comparator | Drug: Duration of antibiotic7 days of Colistin |
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 who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years
Key exclusion criteria (1 listed)
- VAP due to other organisms; (b) pregnancy; (c) endotracheal or tracheostomy tube aspirate demonstrating growth of drug sensitive Acinetobacter baumanii or an organism other than Acinetobacter baumanii; and, (c) failure to provide informed consent.
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 |
|---|---|---|
| Duration of antibioticAlso: ColisitinDuration of antibiotic for treatment of VAP | Drug | Long duration of antibiotics, Short duration of antibiotics |
Primary outcome
Relapses of VAP
Time frame: 28 days
defined as repetitive clinically and microbiologically documented VAP due to the same pathogen
4 secondary outcomes
Duration of mechanical ventilation
Time frame: 28 days
ICU and hospital length of stay
Time frame: 90 days
28-day mortality
Time frame: 28 days
Antibiotic free days
Time frame: 28 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 5 Dec 2025.
- Individual participant dataSharing planned: Undecided. anonymized individual patient information and clinical details will be shared
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of antibiotic in people with Ventilator Associated Pneumonia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 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 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Relapses of VAP (time frame: 28 days). 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 5 Dec 2025.