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

Not Applicable

• Conditions: Skin infections; Pneumonia; Sinusitis; Cystitis; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12615001097538
• Lead Sponsor: elson Bays Primary Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to antibiotic treatment, assessed by daily symptom score. [End of treatment];Relapse of infection, assessed by symptom score at follow up, by restarting of antibiotics and for urine infection by relapse or persistence of positive urine culture. [Day 5 to 7 after treatment stopped and day 14 to 21 after treatment stopped]

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events, such as nausea, vomiting, diarrhoea or skin rash. The patient will be asked about TEAE by the study team at each contact. [Each day during the period of antibiotic treatment and at each follow-up assessment (between days 5 to 7 after treatment finishes and between days 14 and 21 after treatment finishes).];Total consumption of antibiotic doses, assessed by telephone questioning[Daily phone call during antibiotic treatment]