Retrospective Analysis of the Epidemiological Change and Determinants of Prognosis of Talaromycosisof Human Immunodeficiency Virus Negative Host in Guangxi

Study Overview
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Brief Summary
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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.

Official Title
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The First Affiliated Hospital of Guangxi Medical University

Conditions
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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

Intervention / Treatment
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* Other: the multiple programs of antifungal therapy for HIV-negative host


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TSM of HIV-negative Host<br>Eligible patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture. | Other: the multiple programs of antifungal therapy for HIV-negative host<br>* 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.<br>* Other names: their prognosis and recurrence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission rate | Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures. | 7 days | 
| recurrence rate | Relapse of talaromycosis was defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution. | 12 months | 
| mortality at 4 week | all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization. | 4 weeks | 
| toxic side effects | Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly | 24 weeks | 
| mortality at week 24 | The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G test | positive was defined as >20pg/ml | 3 days | 
| GM test | positive was defined as >0.5 | 3 days |