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To compare the efficacy and safety of various antibiotic durations (four versus five versus six weeks) in childhood empyema.

Comparison of four weeks versus five weeks versus six weeks antibiotic therapy in childhood empyema : An open label randomised controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078135
Enrollment
45
Registered
2024-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: J860- Pyothorax with fistula

Interventions

Intervention1: Antibiotics: Intervention : 3 different groups with total antibiotic duration including oral and intravenous of 4 weeks versus 5 weeks versus 6 weeks. Comparator agent : Clinical outc

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children less than 18 years of age with empyema. Empyema defined as pus in pleural cavity with clinical, laboratory and radiological features suggesting pneumonia or parapneumonic effusion

Exclusion criteria

Exclusion criteria: 1. Tubercular Empyema. 2. Empyema secondary to ruptured liver abscess. 3. Empyema secondary to ruptured hydatid cyst. 4. Empyema secondary to Mediastinitis. 5. Empyema secondary to Pancreatitis or Pleuropancreatic Fistula.

Design outcomes

Primary

MeasureTime frame
Clinical worsening in terms of recurrence of fever/respiratory distress/readmission or worsening radiology by x ray or ultrasound requiring any intervention at stopping the antibiotics of prescribed duration that is attributable to empyema.Timepoint: time point at baseline, 4 weeks and 3 months.

Secondary

MeasureTime frame
To document in the incidence of adverse drug effect warranting stoppage of antibiotics or admission during follow up. Marker of Pulmonary function 3 months after discharge viz Spirometry in children = 6 years old, 6-minute walk test in children 3-6 years old. CXR and USG at 3 months after discharge to document resolution of radiological features of empyema and/or residual pleural thickening Timepoint: time points different for different patients at 3 months of age

Countries

India

Contacts

Public ContactRamakrishna M G

Post Graduate Institute of Medical Education and Research

dr.joseph.l.mathew@gmail.com8264400604

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026