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NCT Number: NCT03477292

7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory ICU, Department of Pulmonary Medicine, PGIMER, Chandigarh, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(a) Patients who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years

Exclusion criteria

(a) 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.

Treatment and study plan

Duration of antibiotic

Drug

Duration of antibiotic for treatment of VAP

Other names: Colisitin

Primary outcomes

  1. Relapses of VAP

    Time frame: 28 days

    defined as repetitive clinically and microbiologically documented VAP due to the same pathogen

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: 28 days

    (non-invasive and invasive)

  2. ICU and hospital length of stay

    Time frame: 90 days

    Days spent in ICU and hospital

  3. 28-day mortality

    Time frame: 28 days

    ICU or hospital mortality

  4. Antibiotic free days

    Time frame: 28 days

    Number of days spent without antibiotics

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Study to Compare 7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia Due to Drug Resistant Acinetobacter Baumanii

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2018
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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