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. 2018 Sep 24;2018(9):CD002150. doi: 10.1002/14651858.CD002150.pub2

ISRCTN47812566.

Trial name or title Oral Doxycycline Versus Oral Azithromycin in the Treatment of Scrub and Murine Typhus in Laos
Methods Randomized controlled trial (RCT)
Participants Inclusion criteria

  • Adult (> 15 years) non‐pregnant patients with suspected typhus. Suspected typhus will be defined as undifferentiated fever (aural temperature > 37.5°C), with or without an eschar, with a positive scrub typhus lateral flow IgM result or a murine typhus IgM Dip‐Sticks result

  • Written informed consent to participate in the study

  • Ability to stay in hospital for duration of treatment (up to 7 days) and high likelihood of completing at least 4 weeks of follow‐up

  • Ability to take oral medication

  • Negative urinary pregnancy test for all women of child‐bearing age

  • None of the exclusion criteria


Exclusion criteria

  • Known hypersensitivity to tetracycline, doxycycline, or azithromycin

  • Administration of chloramphenicol, doxycycline, tetracycline, fluoroquinolones, or azithromycin during the preceding week

  • Pregnancy or breast‐feeding

  • Contraindications to doxycycline: severe hepatic impairment, known systemic lupus erythematosus (SLE)

  • Contraindications to azithromycin: severe hepatic impairment

  • Severe typhus defined as:

    • Reduced level of consciousness

    • Clinical jaundice

    • Shock (blood pressure (BP) systolic < 80 mmHg)

    • Vomiting sufficient to disallow the use of oral medication

    • Clinical or radiological evidence of lung involvement

    • Clinical evidence of meningitis/encephalitis or the need for a lumbar puncture (LP)

    • Any other syndrome that in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)
Interventions

  • Oral doxycycline 100 mg every 12 hours for 7 days (after a 200‐mg loading dose)

  • Doxycycline 100 mg every 12 hours for 3 days (after a 200‐mg loading dose)

  • Oral azithromycin 500 mg on day 1, then 250 mg every 24 hours for 2 more days
Outcomes

  • Fever clearance time

  • Frequencies of treatment failure

  • Frequencies of relapse

  • Treatment failure frequency

  • Relapse frequency
Starting date 4 August 2003
End of follow‐up: 31 December 2009
Contact information Dr. Paul Newton
paul@tropmedres.ac; Ministry of Health, Mahosot Hospital, Mahosot Road, Vientiane, Laos
Notes Location: Mahosot Hospital, Vientiane, Laos
Registration number: ISRCTN47812566
Source of funding: The Wellcome Trust (UK) (grant ref: 066828)