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A CLINICAL TRIAL TO STUDY THE EFFICACY BETWEEN TWO DRUGS AZITHROMYCIN AND DOXYCYCLINE AND THEIR COMBINATION IN TREATING COMPLICATED SCRUB TYPHUS

COMPARING EFFICACY OF AZITHROMYCIN, DOXYCYCLINE, AND COMBINATION THERAPY IN TREATMENT OF COMPLICATED SCRUB TYPHUS: A TRIPLE BLINDED RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028236
Enrollment
114
Registered
2020-10-05
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: DOXYCYCLINE: Doxycycline is a synthetic, broad-spectrum tetracycline antibiotic exhibiting antimicrobial activity. Doxycycline binds to the 30S ribosomal subunit, possibly to the 50S ri

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients within the age defined criteria who presented with severe scrub typhus (reduced level of consciousness, clinical jaundice, shock, vomiting severe enough to disallow the use of oral medications, clinical or radiological evidence of lung involvement, clinical evidence of meningitis/encephalitis or the need of a lumbar puncture, any other syndrome that in the opinion of the admitting doctor constitutes severe scrub typhus (reason stated by the treating physician), ability to stay in the hospital for the duration of treatment (duration of 7 days) and a high likelihood of completing at least 4 weeks follow up, negative pregnancy test for all women of childbearing age-as from history and/or negative urinary pregnancy test

Exclusion criteria

Exclusion criteria: participants who are contraindicated to doxycycline and azithromycin or both, patients who had taken chloramphenicol, tetracycline, or ciprofloxacin during the previous 48 hours, pregnancy or breastfeeding, long term use of immunosuppressant (eg. steroids, chemotherapy, TNF-inhibitors) and use of HAART for HIV patients, have a non-infectious cause of pulmonary infiltrates, have or be at risk for major cardiac events or dysfunction, received within 7 days before enrollment of class Ia or Class III anti-arrhythmic medication, end-stage renal disease (stage 5)

Design outcomes

Primary

MeasureTime frame
Primary Outcome: To compare the fever clearance time between patients in specific treatment groups, to compare the rate of resolution of laboratory parameters towards normalization between the treatment groups Timepoint: 48 to 72 hours

Secondary

MeasureTime frame
26. Secondary Outcome:Treatment failure rates among patients with various organ specific involvements as a complication of scrub typhus, any other presentations unaccounted previously. Timepoint: 48 to 72 hours

Countries

India

Contacts

Public ContactDr Prasan Kumar Panda

Aiims, Rishikesh

prasan.med@aiimsrishikesh.edu.in08800103011

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026