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CTRI Number  CTRI/2024/12/078135 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the efficacy and safety of various antibiotic durations (four versus five versus six weeks) in childhood empyema. 
Scientific Title of Study   Comparison of four weeks versus five weeks versus six weeks antibiotic therapy in childhood empyema : An open label randomised controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramakrishnan M G  
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Pediatric pulmonology division, Block 4 c Advance Pediatric Centre PGIMER Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  7418987653  
Fax    
Email  ramakrishganesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Joseph L Mathew 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no : 3118 Block 3A Advance Pediatric Centre PGIMER
Sector 12 Madhya marg
Chandigarh
CHANDIGARH
160012
India 
Phone  8264400604  
Fax    
Email  dr.joseph.l.mathew@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ramakrishna M G 
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Pediatric Pulmonology Division Block 4 c PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7418987653  
Fax    
Email  ramakrishganesh@gmail.com  
 
Source of Monetary or Material Support  
Advance Pediatric Centre PGIMER, Chandigarh Chandigarh Pincode- 160012 India 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Madhya Marg, Sector 12, Chandigarh-160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M G Ramakrishnan  Post Graduate Institute of Medical Education and Research  Pediatric Pulmonology Division, Block 4C Advanced Pediatric Centre, Sector 12 Madhya marg Chandigarh Pincode - 160012 India
Chandigarh
CHANDIGARH 		 7418987653

ramakrishganesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee postgraduate institute of medical education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J860||Pyothorax with fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 outcome in terms of recovery in 3 different groups of the trial 
Comparator Agent  Comparator agent : Clinical outcome in terms of recovery in 3 different groups of the trial  clinical worsening in terms of recovery and need for additional interventions in the form of readmission, recurrence of symptoms. pulmonary function test for children more than 6 years of age 
 
Inclusion Criteria  
Age From  28.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

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. 		 time point at baseline, 4 weeks and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 time points different for different patients at 3 months of age 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Empyema is defined as pus in pleural cavity. There are no Indian guidelines on empyema. There are no studies suggesting optimal duration of antibiotics in empyema in children. SLIM trail that compared short course (14-42 days) versus long course (7-21 days) antibiotic therapy did not find any statistically significant reduction in incidence of treatment failure of empyema in children(16). Hence by comparing 4 weeks vs 5 weeks 6 weeks duration of antibiotic will help in guiding optimal duration of antibiotics in empyema in children. Evidence supporting short course antibiotic therapy will help in reducing cost of treatment on the patient’s perspective, improve compliance and adherence to therapy. 

This prospective study is based on hypothesis that 4 weeks of antibiotics may be as effective as 5 or 6 weeks of antibiotics. Study design will be open label placebo controlled randomised control multiple arm trial. Children less than 18 years with empyema will be included and randomised in one of the three groups with different antibiotics duration. The treatment failure will be assesed by requirement of antibiotics beyond the prescribed duration or any additional intervention within 3 months of follow up.

 
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