Clinical trial NCT03819348: Retrospective Analysis of the Epidemiological Change and Determinants of Prognosis of Talaromycosisof Human Immunodeficiency Virus Negative Host in Guangxi
Official title: The First Affiliated Hospital of Guangxi Medical University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis
To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
name: The Fourth People's Hospital of Nanning
name: Guilin Medical College
name: Nanning Second People's Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
First posted: 2019-01-28
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We studied the clinical characteristics and prognoses of patients with infections due to Talaromyces marneffei who were admitted to Guangxi Hospital, This province is located in subtropical southern China, where Talaromyces marneffei is endemic.

Brief summary: Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. Improve the level of understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by either microscopy or culture.

Exclusion Criteria:

* patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.

Primary outcomes:
measure: clinical remission rate
timeFrame: 7 days
measure: recurrence rate
timeFrame: 12 months
measure: mortality at 4 week
timeFrame: 4 weeks
measure: toxic side effects
timeFrame: 24 weeks
measure: mortality at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: G test
timeFrame: 3 days
measure: GM test
timeFrame: 3 days
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Medical University
state: Guangxi
Study officials:
References:
citation: Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.