| CTRI Number |
CTRI/2019/01/017012 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
22/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ORAL AZITHROMYCIN VS DOXYCYCLINE IN TREATMENT OF CHILDREN WITH SCRUB TYPHUS WITHOUT COMPLICATIONS |
|
Scientific Title of Study
|
ORAL AZITHROMYCIN VS DOXYCYCLINE IN TREATMENT OF CHILDREN WITH SCRUB TYPHUS WITHOUT COMPLICATIONS - AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joseph John |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences,
P.O. Dumduma
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7559936936 |
| Fax |
|
| Email |
drjj@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseph John |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences,
P.O. Dumduma
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7559936936 |
| Fax |
|
| Email |
drjj@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthika I K |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Pediatrics,
All India Institute of Medical Sciences,
P.O. Dumduma
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8086197733 |
| Fax |
|
| Email |
karthika1230893@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr Joseph John |
| Address |
Additional Professor,
Department of Pediatrics,
All India Institute of Medical Sciences,
Bhubaneswar - 751019 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amit Kumar Satapathy |
Assistant Professor,
Department of Pediatrics,
All India Institute of Medical Sciences,
Bhubaneswar - 751019 |
| Dr Bijayani Behera |
Associate Professor, Department of Microbiology,
AIIMS, Bhubaneswar |
| Dr Biswa Mohan Padhy |
Associate Professor, Department of Pharmacology AIIMS, Bhubaneswar. |
| Dr Karthika I K |
Keerthanam, Palappuram P.O. Ottapalam, Palakkad
Kerala 679103 |
| Dr Suchanda Sahu |
Associate Professor, Department of Biochemistry,
AIIMS, Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joseph John |
All India Institute of Medical Sciences |
Department of Pediatrics,
All India Institute of Medical Sciences,
P.O. Dumduma Bhubaneswar
Khordha
ORISSA |
759936936
drjj@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bhubaneswar |
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 |
10mg/Kg/Day once daily for 5 days |
| Comparator Agent |
Doxycycline |
4.5mg/kg/day divided Q 12 Hourly for 5 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients falling under the ‘suspected, probable and confirmed case definitions ‘ as per IAP guidelines on Ricketssial diseases in children based on clinical and epidemiological criterias |
|
| ExclusionCriteria |
| Details |
Patients with a known allergy to either of these drugs
Patients participating in other clinical trials
Children with any other known systemic illness
Children with any major congenital malformations Â
Children who have received antimicrobial drugs with antirickettsial activity in the preceeding 2 weeks (doxycycline/azithromycin/chloramphenicol/rifampicin) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two drugs in terms of percentage of children who attained remission of fever after 72 hours of administration of first dose of the study drug |
After 72 hours of administration of first dose of the study drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical resolution of hepatosplenomegaly and lymphadenopathy.
|
On a daily basis |
Time required for normalization of
a)Liver enzymes - AST and ALT between 40 U/L
b)Thrombocytopenia - Platelet count 1.5 lakhs
c)Hyponatremia - Serum Sodium 135 mEq/L
d)Hypoalbuminemia- Albumin 3.5g/dL |
On Day 3 and Day 5 and in selected cases who have not responded to repeat after 1 week of administration of the study drug |
| Adverse drug events of the medications being used |
On a daily basis |
| Rate of treatment failures |
After 72 hours |
| Time taken for defervescence of fever for either drug after the first dose of drug |
Monitored every 4 hourly |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
30/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objectives -
To compare the efficacy of Azithromycin versus Doxycycline in treatment of
children with uncomplicated scrub typhus in terms of percentage of children who
attained remission of fever after 72 hours of administration of first dose of
the study drug, mean time taken to attain fever defervescence, normalisation of
laboratory parameters, resolution of hepatosplenomegaly and lymphadenopathy.
Design – Interventional,
Open labelled Randomized Controlled Trial
Study methods - Patients
admitted with undifferentiated fever in the In-Patient Department (IPD),
Department of Paediatrics, All India Institute of Medical Sciences, Bhubaneswar
as per the inclusion criteria were randomised and was treated with Azithromycin
at 10mg/kg/day in one group and Doxycycline at 4.4mg/kg/day in the other group
and was assessed based on the primary and secondary objectives.
Results - There
was no statistically significant difference between the percentage of children
who attained remission of fever after 72 hours of administration of Azithromycin
(98%) and Doxycycline (96%) (p value-0.48) and the average time taken for fever
defervescence (Azithromycin – 24.6 hours Doxycycline – 25.7 hours, p value-
0.32). The odds of attaining fever remission in Doxycycline group as compared
to Azithromycin group was 0.62 (95 % confidence interval (CI) - (0.16 – 2.3)) which was also statistically
not significant. There was less incidence of adverse drug events in
Azithromycin group (1.96%) as compared to Doxycycline group (9.09%) which was
statistically significant (p value-0.01).
Conclusion -
Azithromycin is equally efficacious in terms of fever defervescence, resolution
of clinical signs and laboratory parameters as Doxycycline and is safer and
more tolerated in children. |