| CTRI Number |
CTRI/2025/01/079498 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Azithromycin versus Doxycycline for treatment of Scrub Typhus in children |
|
Scientific Title of Study
|
Comparison of oral Azithromycin versus oral Doxycycline in children with Scrub Typhus A randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUNKARA KRISHNA AISWARYA |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Department of Paediatrics,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8374696298 |
| Fax |
|
| Email |
aiswarya.krishna01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B HEMANTH KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Department of Paediatrics,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9655738271 |
| Fax |
|
| Email |
drhemanthbhk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUNKARA KRISHNA AISWARYA |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital,Puducherry |
| Address |
Department of Paediatrics,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8374696298 |
| Fax |
|
| Email |
aiswarya.krishna01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry -605107,India |
|
|
Primary Sponsor
|
| Name |
SUNKARA KRISHNA AISWARYA |
| Address |
Department of Paediatrics,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry -605107 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSUNKARA KRISHNA AISWARYA |
Sri Manakula Vinayagar Medical College and Hospital |
Room no 49,Department of Paediatrics, Kalitheerthalkuppam,Madagadipet,Puducherry-605107
Pondicherry
PONDICHERRY |
8374696298
aiswarya.krishna01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH - ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Oral Azithromycin 10mg/kg once daily for 5 days with a maximum dose of 500mg/day |
| Comparator Agent |
Doxycycline |
Oral Doxycycline 4.4 mg/kg/day for 5 days with a maximum dose of 200mg/day |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.All children with clinical and microbiologically proven scrub typhus of all paediatric age group admitted in paediatric ward. |
|
| ExclusionCriteria |
| Details |
1.children of parents who refused to give consent
2.Children with known allergy to either of these two drugs
3.Children who received anti microbials like Azithromycin or Doxycycline in proceeding 2 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the time taken for fever defervescence in two groups one using azithromycin and the other using doxycycline |
Temperature of the patient is checked every 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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 4 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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)
|
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
|
This prospective randomized controlled study will be performed in the paediatric ward of Sri manakula vinayagar medical college and hospital a tertiary care hospital in Puducherry after the approval of research committee and institutional ethics committee.Children who fulfill the criteria will be included in the study after the informed and written consent is being obtained from the parents
Enrolled children will be randomized using computer generated randomized sequence into two groups by using sequentially numbered sealed envelopes which will be opened by the post graduate or intern and the intervention written will be administered to the patient.children allocated in group A receive oral Azithromycin and children allocated in group B receive oral doxycycline .In case of any deterioration of the patient clinically or no improvement in the patient even after 72 hours after treatment patient was classified as treatment fail and alternative treatment will be started to the patient or if any alternative diagnosis was concluded because of other investigations sent they should be medically managed with the respective drugs and they will be excluded from the study. Aprincipal investigator will assess the time taken for the defervescence of fever and duration of hospital stay between Azithromycin and doxycycline group .
|