Randomised Empirical Antibiotic Duration in Intensive Care Unit

A pilot randomised controlled trial comparing seven days versus two days of empirical antibiotics to treat hospital acquired infection of unknown origin in intensive care patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82694288

Enrollment

Registered

2009-08-26

Start date

2009-11-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthcare-associated infections/sepsis Infections and Infestations

Interventions

Seven days versus two days of empirical antibiotics.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in the intensive care unit suspected of having infection of unknown origin will be eligible for inclusion if they are: 1. Both males and females, at least 18 years of age 2. Assent given by relatives/legal representative and written consent reaffirmed once the patient gets better. If patient is able to give informed consent this has to be given in writing.

Exclusion criteria

Exclusion criteria: 1. Positive blood cultures pre-randomisation 2. Patients currently enrolled in any other study where involvement in this pilot study would risk deviation from either protocols 3. Allergy to treatment antibiotics

Design outcomes

Primary

Measure	Time frame
The rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. All outcome measures will be assessed at day 10 or at hospital discharge, whichever is sooner.	—

Secondary

Measure	Time frame
1. Clinical 1.1. Duration of ICU stay 1.2. Duration of Hospital stay 1.3. Duration of mechanical ventilation 1.4. Incidence of infection with clostridium difficile 1.5. Incidence of infection with MRSA 2. Economic 2.1. Resource utilisation and costs 3. Feasibility outcomes 3.1. The ratio of patients - screened : eligible : randomised 3.2. The incidence of cross-over between the randomised treatment groups 3.3. The accuracy of data collection assessed by a 20% source data verification check All outcome measures will be assessed at day 10 or at hospital discharge, whichever is sooner.	—

Measure

Time frame

1. Clinical 1.1. Duration of ICU stay 1.2. Duration of Hospital stay 1.3. Duration of mechanical ventilation 1.4. Incidence of infection with clostridium difficile 1.5. Incidence of infection with MRSA 2. Economic 2.1. Resource utilisation and costs 3. Feasibility outcomes 3.1. The ratio of patients - screened : eligible : randomised 3.2. The incidence of cross-over between the randomised treatment groups 3.3. The accuracy of data collection assessed by a 20% source data verification check All outcome measures will be assessed at day 10 or at hospital discharge, whichever is sooner.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026