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Scrub Typhus Antibiotic Resistance Trial
Bu çalışma, scrub typhus (çalılık tifüsü) enfeksiyonunun tedavisinde farklı antibiyotik rejimlerini (7 günlük Doxycycline, 3 günlük Doxycycline ve 3 günlük Azithromycin) karşılaştırmaktadır. Çalışmaya, akut ateşle hastaneye başvuran ve scrub typhus tanısı doğrulanan 15 yaş ve üzeri hastalar katılmaktadır. Çalışma Faz 4 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Age ≥ 15 years old * Hospitalization with acute undifferentiated fever (temperature \> 37.5°C, tympanic) ≤14 days or patients admitted to hospital with a history of fever ≤ 14 days who subsequently develop fever within 24 hours of admission * Clinically suspected scrub typhus: defined as acute undifferentiated fever with no clear focus of infection and negative malaria blood smear and/or negative malaria RDT. Patients may have one, none, or a combination of other clinical findings such as eschar, rash, lymphadenopathy, headache, myalgia, cough, nausea and abdominal discomfort. * A positive scrub typhus RDT (Scrub Typhus IgM RDT, InBios International, Seattle, WA, USA) and/or positive PCR-based detection of O. tsutsugamushi DNA from the admission blood sample * Written informed consent and/or, written informed assent as required * Able to take oral medication Exclusion Criteria: * Known hypersensitivity to tetracycline, doxycycline or azithromycin * Administration of doxycycline, azithromycin, chloramphenicol, rifampicin, or tetracycline during the preceding 7 days * Pregnancy or breast-feeding * Patients with myasthenia gravis or systemic lupus erythematosus * Patients with an established infection (diagnostic test required) e.g. acute malaria, dengue, leptospirosis, typhoid, Japanese encephalitis etc. * Current TB or TB treatment in ≤ 6 months (contain active antibiotics against Orientia spp.) * Current HAART use for HIV, long term use of immunosuppressants (e.g. steroids, chemotherapy, TNF-inhibitors and related agents) * Patients with severe disease whom the clinical team feel their condition necessitates the need for additional scrub typhus treatment beyond the allocated antibiotic treatment assigned at randomization (e.g. IV chloramphenicol and/or PO/NG rifampicin)