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Doxycycline versus azithromycin in pediatric scrub fever

Open labelled randomized controlled trial on efficacy of azithromycin versus doxycycline in pediatric scrub typhus.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022991
Enrollment
60
Registered
2020-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushi

Interventions

Intervention1: Azithromycin: 10mg/kg/day for 5 days Control Intervention1: 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

Sponsors

Director Principal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 37.8Ë?C and is maintained for 48 hours without antipyretics. Timepoint: defervescence within 5 days of starting DX or AZ.

Secondary

MeasureTime frame
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. Timepoint: day5,7, 1 month

Countries

India

Contacts

Public ContactAnjali Sharma

Government Medical College and Hospital

vidushimahajan2003@yahoo.co.in9646121531

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026