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CTRI Number  CTRI/2020/01/022991 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 18/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Doxycycline versus azithromycin in pediatric scrub fever 
Scientific Title of Study   Open labelled randomized controlled trial on efficacy of azithromycin versus doxycycline in pediatric scrub typhus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidushi Mahajan 
Designation  Assistant Professor Pediatrics 
Affiliation  Government Medical College and Hospital 
Address  RNO. D-411, Level 4, D block, Pediatric office, Dept. of pEdiatrics, GMCH-32, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121531  
Fax    
Email  vidushimahajan2003@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Vidushi Mahajan 
Designation  Assistant Professor Pediatrics 
Affiliation  Government Medical College and Hospital 
Address  RNO. D-411, Level 4, D block, Pediatric office, Dept. of pEdiatrics, GMCH-32, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121531  
Fax    
Email  vidushimahajan2003@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anjali Sharma 
Designation  Junior Resident Pediatrics 
Affiliation  Government Medical College and Hospital 
Address  Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121531  
Fax    
Email  sharmaanjali2362@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and hospital Chandigarh 
 
Primary Sponsor  
Name  Director Principal 
Address  Government Medical College and Hospital, Sector 32, Chandigarh 
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 
Vidushi Mahajan  Government Medical College and Hospital  RNO. D-411, Level 4, D block, Pediatric office, Dept. of pEdiatrics, GMCH-32, Sector 32, Chandigarh
Chandigarh
CHANDIGARH 		 964621531

vidushimahajan2003@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Government Medical College and Hospital Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A753||Typhus fever due to Rickettsia tsutsugamushi,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azithromycin  10mg/kg/day for 5 days 
Comparator Agent  Doxycycline  2.2 mg/kg/ dose BD in children less than 40 kg and 100 mg BD in children more than 40 kg for 7 days 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children admitted in the hospital will be eligible for enrollment if they fulfill the following inclusion criteria:
Children 6 months to 18 years suffering from acute febrile illness of 5 days or more and scrub typhus IgM serology positive by ELISA (cutoff optical density 0.5 or more)
 
 
ExclusionCriteria 
Details  Patients will be excluded from study if :
1. History of hypersensitivity to macrolides or tetracylines. 
2. Indications of presence of a febrile illness unrelated to scrub typhus. 
3. Patients who had ingested any agents with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, or tetracycline) within 48 hours prior to randomization.
4. Patient with heart disease.
5. Post randomization scrub IgM serology negative in case of critically sick patients who are randomized awaiting scrub serology.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Our primary outcome shall be the proportion of children achieving defervescence within 5 days of starting DX or AZ. Defervescence is defined as the interval between the time at which first dose of antibiotic is administered  and the time at which the axillary temperature falls below 37.8˚C and is maintained for 48 hours without antipyretics.
 		 defervescence within 5 days of starting DX or AZ.
 
 
Secondary Outcome  
Outcome  TimePoints 
Additionally participants will be assessed for hospitalization duration, time to defervescence, need for ventilation, inotropic support, blood transfusion, renal replacement therapy and any adverse event.
 		 day5,7, 1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 1 
Date of First Enrollment (India)   30/01/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In a PRISMA - compliant systematic review and meta- analysis, it was concluded that azithromycin is as effective as other anti-rickettsial drugs with higher treatment success rates, lower adverse effects, and longer time to defervescence14. However, all these studies were done on adult population. Recent Cochrane review tried to find out whether certain antibiotics are more effective in treating scrub typhus19. For specific outcomes, low certainity evidence suggests that there may be little or no difference between tetracycline, doxycycline and azithromycin19. Thus, there is limited but promising data regarding efficacy and optimal dosage of azithromycin for treatment of  scrub typhus especially in children. Hence, we planned this study to compare the efficacy of azithromycin with doxycycline in children  suffering from scrub typhus.

 
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