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

To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis Clinical Trial

— RAECDPT  

Official title:

The First Affiliated Hospital of Guangxi Medical University

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03819348
• Other study ID #: RA-TSM-HIVN-ECDP
• Status: Active, not recruiting
• Start date: January 1, 2003
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2019
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Recurrence
• 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

Other:
• the multiple programs of antifungal therapy for HIV-negative host
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.

Locations

Country	Name	City	State
China	Guangxi Medical University	Nanning	Guangxi

Sponsors (6)

Lead Sponsor	Collaborator
Guangxi Medical University	Guilin Medical College, Nanning Second People's Hospital, People's Hospital of Guangxi, Second Affiliated Hospital of Guangzhou Medical University, The Fourth People’s Hospital of Nanning

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	G test	positive was defined as >20pg/ml	3 days
Secondary	GM test	positive was defined as >0.5	3 days

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