CompletedNot Applicable

Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections

Israel600 participantsStarted 2016-04

Plain-language summary

Severe bacterial infections are associated with mortality of about 30%. Patients with moderate to severe bacterial infections given early and appropriate empirical antibiotic treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous treatment. TREAT is a computerized decision support system for antibiotic treatment in inpatients with common bacterial infections. TREAT is based on a state of the art stochastic model of the domain (a causal probabilistic network) and uses a cost benefit model for antibiotic treatment, including costs assigned to future resistance. It was tested in a randomized controlled trial in 3 countries and shown to improve the percentage of appropriate empirical antibiotic treatment while at the same time reduce hospital stay and the use of broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited information available within hours of presentation. A second attractive approach to improve antibiotic treatment is to use techniques that do not depend on cultures, and thus shorten the time to identification of the pathogen to a few hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid amplification test for pathogens causing bloodstream infections. The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will improve the outcome of inpatients with moderate to severe bacterial infections, while at the same time reducing the use of broad-spectrum antibiotics, with no or little additional costs. A secondary objective will be to assess the sensitivity and specificity of whole blood PCR, using TREAT as the reference standard.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients from whom blood cultures were drawn or
✓. All patients for whom antibiotic treatment (but not prophylaxis or intra-peritoneal, inhalation or local antibiotics therapy ) is started within the last 96 days or
✓. Patients fulfilling the CDC diagnostic criteria for any infection (see appendix C) or
✓. Patients with temperature ≥38.3 measured orally (or 38 axillary or 38.5 rectal) on a single measurement or ≥38 / \< 36 on at least 2 consecutive measurements separated at least 1 hr apart and one of the next criteria:
✓. Patients with shock compatible with septic shock. As defined as hypotension (arterial blood pressure \<90 mmHg systolic, or 40 mmHg less than patient's normal blood pressure) for at least 1 h despite adequate fluid resuscitation; Or Need for vasopressors to maintain systolic blood pressure \>90 mmHg or mean arterial pressure \>70 mmHg and a suspected source of infection.

Exclusion criteria

✕. HIV positive patients with opportunistic infection (suspected or proven)and / or AIDS defining illness in the last 6 months prior to data collection.
✕. Children\<18 years.

What they're measuring

Clinical success defined as 30-day survival and clinical stability on day 4

Timeframe: 30 days

Trial details

NCT IDNCT01338116

SponsorRabin Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-13

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