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Randomized trial of the efficacy and rate of relapse of bacterial infections using standard versus symptom-based antibiotic duration in primary-care patients

Randomized trial of the efficacy and rate of relapse of bacterial infections using standard versus symptom-based antibiotic duration in primary care patients.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001097538
Acronym
None
Enrollment
71
Registered
2015-10-19
Start date
2015-11-20
Completion date
2016-01-27
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

When a doctor prescribes antibiotics, the usual advice is to finish the course. Instead, patients often stop taking the antibiotics when they feel better. This trial is designed to find out which strategy is better for a variety of mild to moderate infections treated in the community. More and more information now shows that shorter courses of antibiotics work as well as longer courses for many mild to moderate infections and that success can be predicted by certain symptoms of infection going away. A shorter course of antibiotics is likely to cause fewer side effects and less resistance. A longer course of antibiotics, in those who are slow to get better, may prevent the infection coming back. This is the first randomised trial we are aware of that formally tests whether it is best to finish a course of antibiotics or stop when the symptoms have substantially gone away. we hypothesise that a symptom-based duration of antibiotic treatment will be equal or more effective than a standard course, with equal or less antibiotic consumption and treatment-emergent adverse effects.

Interventions

The antibiotic course will be stopped when the patient's symptoms have substantially subsided. The investigators will advise the patient when to stop antibiotics, based on symptoms scores assessed daily while taking antibiotics. The criteria for stopping antibiotics, based on a symptom severity score of 1 (very mild) to 10 (most severe) will be all of the following: 1. More than 3 days after onset of symptoms 2. Symptom score 2 or less for feverishness (chills, sweats) and pain 3. Symptom scor

The antibiotic course will be stopped when the patient's symptoms have substantially subsided. The investigators will advise the patient when to stop antibiotics, based on symptoms scores assessed daily while taking antibiotics. The criteria for stopping antibiotics, based on a symptom severity score of 1 (very mild) to 10 (most severe) will be all of the following: 1. More than 3 days after onset of symptoms 2. Symptom score 2 or less for feverishness (chills, sweats) and pain 3. Symptom score 3 or less or back to baseline for loss of appetite, body ache, skin symptoms/signs (redness, heat, swelling - if skin infection), urinary symptoms (dysuria, frequency - if urinary infection), cough improving (if chest infection), less than 50% volume of purulent sputum (if chest infection), less than 50% volume of nasal discharge or post-nasal drip (if sinus infection) 4. The patient feels ready to stop antibiotics. Adherence will be checked each day during antibiotic treatment.

Sponsors

Nelson Bays Primary Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Outpatients only Skin infection - surface area > square 75 cm Pneumonia - using scoring system from local acute cough algorithm Sinusitis - criteria for antibiotic treatment from Australian Therapeutic Guidelines 2014 Bladder infection - compatible symptoms plus bacteruria

Exclusion criteria

Severe infections or hospitalised patients. Substantial immune compromise Treatment failure for same infection in past 3 months Other antibiotic treatment within 4 days of enrolement. Infection found to be caused by bacteria resistant to those prescribed Skin infection requiring more complex or prolonged treatment, such as necrotising infection, diabetic foot infections or infection complicating severe peripheral vascular disease, decubitus ulcer infection, animal or human bite infection, infection complicating fresh water or salt water trauma, or infection associated with a vascular, enteric or urinary catheter site, underlying osteomyelitis or septic arthritis, or a recent deep surgical wound. Chest infections requiring more complex or prolonged treatment, such as infective exacerbations of bronchiectasis or cystic fibrosis, empyema. Sinus infection involving the orbit or intra-cranial structures Pyelonephritis, prostatitis or indwelling urinary catheter

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026