Treatment for murine and scrub typhus infections

A Pharmacokinetic-pharmacodynamic Study of Early Rickettsia Clearance in Murine Typhus or Scrub Typhus Patients Treated with Doxycycline or Azithromycin

This study is testing if the antibiotics doxycycline and azithromycin can effectively treat adults with murine and scrub typhus infections while they are hospitalized.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (Academic / other)
• Locations: 2 sites (Vientiane, Vientaine and 1 other locations)
• Trial ID: NCT05972772 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on evaluating the effectiveness of doxycycline and azithromycin in treating murine typhus and scrub typhus, two infectious diseases caused by rickettsial bacteria. Participants will be adults who test positive for these infections and agree to stay in the hospital for at least 36 hours for treatment and follow-up. The study aims to improve diagnosis and treatment options for these diseases, which have significant mortality rates if left untreated. The trial is conducted at the Lao-Oxford-Mahosot Hospital and Vientiane Provincial Hospital in Laos.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have tested positive for murine typhus or scrub typhus and can take oral medication.

Not a fit: Patients who are pregnant, breastfeeding, or have severe forms of typhus or contraindications to the study medications will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for murine and scrub typhus, potentially reducing mortality rates associated with these infections.

How similar studies have performed: Other studies have shown varying success with similar antibiotic treatments for rickettsial infections, but this specific approach is being evaluated in a novel context.

Eligibility criteria

Inclusion Criteria:

* Age above or equal 18 years
* Able to take oral medication
* Rapid test positive for murine typhus or scrub typhus
* Agrees to stay in hospital for at least 36 hours and to attend for scheduled follow up visits
* Written informed consent to participate in the study
* A negative urinary pregnancy test for all women of child-bearing age

Exclusion Criteria:

* Pregnancy or breast feeding
* Previous allergic reaction to doxycycline or azithromycin
* Received more than one dose of chloramphenicol, doxycycline, tetracycline, fluoroquinolones, rifampicin or azithromycin during this hospital admission or more than one dose of any of these drugs in the week before admission
* Contraindication to doxycycline: severe hepatic impairment, known SLE
* Contraindication to azithromycin: sever hepatic impairment
* Severe typhus defined as the presence of one or more of the following:

  1. Reduced level of consciousness
  2. Clinical jaundice
  3. Shock (BP systolic \<80 mmHg)
  4. Unable to take oral medication
  5. Radiological evidence of pneumonia
  6. Clinical evidence for meningitis/encephalitis or the need of LP
  7. Alternative diagnosis confirmed that explains the presenting symptoms
  8. Any other syndrome which in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)

Where this trial is running

Vientiane, Vientaine and 1 other locations

• Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU) — Vientiane, Vientaine, Laos (Recruiting)
• Vientiane Provincial Hospital — Vientiane Province, Vientiane Province, Laos (Recruiting)

Study contacts

• Principal investigator: Weerawat Phuklia, PhD — Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
• Study coordinator: Weerawat Phuklia, PhD

Conditions Infectious Disease; Therapeutics; Scrub Typhus; Typhus, Endemic Flea-Borne