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

NCT ID: NCT03819348

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-01

Study Completion Date

2019-06-30

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.

Detailed Description

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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TSM of HIV-negative Host

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

the multiple programs of antifungal therapy for HIV-negative host

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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their prognosis and recurrence

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The Fourth People's Hospital of Nanning

OTHER

Sponsor Role collaborator

Guilin Medical College

OTHER

Sponsor Role collaborator

Nanning Second People's Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qiu Ye

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangxi Medical University

Nanning, Guangxi, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 28614691 (View on PubMed)

Related Links

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Other Identifiers

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RA-TSM-HIVN-ECDP

Identifier Type: -

Identifier Source: org_study_id

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