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

NCT03819348 | Unknown DMC

• 1 other identifier: RA-TSM-HIVN-ECDP
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• G test

  3 days

• GM test

  3 days

Study Arms (1)

TSM of HIV-negative Host

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

Interventions

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

Also known as: their prognosis and recurrence

TSM of HIV-negative Host

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangxi Medical University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The Fourth People's Hospital of Nanning: collaborator
• Guilin Medical College: collaborator
• Nanning Second People's Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator

Study Sites (1)

Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related 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 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.

  PMID: 28614691 RESULT

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: January 1, 2003
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)