Study on the cause of body temperature variation
- Conditions
- Fever, unspecified,
- Registration Number
- CTRI/2022/06/043246
- Lead Sponsor
- Indian Academy of Pediatrics Mumbai IAPM
- Brief Summary
There is a high prevalence of antimicrobial resistance among the bacterial isolates of blood stream infections among Indian children. Misuse of antibiotics is an important factor for accelerating the resistance mechanisms among bacteria. Presently physicians rely on their clinical skills to decide on prescribing an antibiotic and these skills vary from individual to individual. There is a clear need for a clinical scoring tool which can be conveniently utilized in the first visit of a child presenting with an acute febrile illness and which can most accurately rule out bacterial infections requiring antibiotics in the first four days of illness. For a better acceptance, this tool needs to be reliable, inexpensive, non invasive and simple for use in a resource limited setting
The data obtained regarding the characteristics of fever will be converted into a score. This will be used to put down a provisional diagnosis of bacterial infection or no bacterial infection. Bacterial infection is assigned lower points and higher points for other causes. Points are assigned as per the importance of relevance for differentiation. Inter-febrile period is the most important point of difference and hence assigned 3 points in favour of non-bacterial and 0 point for bacterial infection.
An independent observer will record the observations/data required to use the clinical tool without interfering with the patient management by the primary pediatrician. Therefore there are no indirect or direct benefit or risk to the patients during the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 2115
Healthy children between age of 6 months and 18 years presenting with acute onset of fever of short duration without exposure to antibiotics in last two weeks.
- Children with following diseases acute severe acute malnutrition, known congenital defects or diseases, serious situations (Behavior change, poor urine output, respiratory distress, hemodynamic instability, purpuric rash or gangrenous skin, meningeal signs).
- Children who have received antibiotics in the first 48 hrs since the onset of fever.
- Post vaccination fever.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate a clinical score to suspect or rule out acute bacterial infection during first 3-4 days of fever by analysis of detailed history 14 days
- Secondary Outcome Measures
Name Time Method To evaluate the proportion of children in whom use of antibiotics is not justified. To evaluate the utility of the tool to reduce irrational use of antibiotics among children
Trial Locations
- Locations (23)
Anand Children’s Nursing Home
🇮🇳(Suburban), MAHARASHTRA, India
Apollo Hospitals
🇮🇳Thane, MAHARASHTRA, India
Bakul Parekh Children’s Hospital and tertiary care center
🇮🇳(Suburban), MAHARASHTRA, India
Bandra East Nursing Home
🇮🇳(Suburban), MAHARASHTRA, India
Child Care Clinic
🇮🇳Thane, MAHARASHTRA, India
Colours Multispeciality Hospital for Children
🇮🇳Thane, MAHARASHTRA, India
Dawood multispeciality hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Amruta Shirodkar’s Clinic
🇮🇳(Suburban), MAHARASHTRA, India
Dr Prashant’s Children’s Clinic
🇮🇳Thane, MAHARASHTRA, India
Dr Sane’s clinic
🇮🇳Thane, MAHARASHTRA, India
Scroll for more (13 remaining)Anand Children’s Nursing Home🇮🇳(Suburban), MAHARASHTRA, IndiaDr Naresh ThakkerPrincipal investigator9821701207nareshthakker@hotmail.com