Skip to content

Population pharmacokinetic/pharmacodynamic of voriconazole for HIV-associated Talaromycosis marneffei

Population pharmacokinetic/pharmacodynamic of voriconazole for HIV-associated Talaromycosis marneffei

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079398
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Talaromycosis marneffei

Interventions

Voriconazole treatment group:NA

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: ( 1 ) Age = 18 years ; ( 2 ) HIV diagnosis ; ( 3 ) Diagnosis of Talaromycosis marneffei, diagnostic criteria ( with ? and ???? in any one ) : ? Clinical syndrome with Talaromycosis marneffei ( fever, weight loss, anemia, lymphadenopathy, Liver and spleen enlargement, etc. ) ; ? Culture-confirmed talaromycosis marneffei ( Specimens may come from blood, bone marrow, skin rash or skin secretions, lymph node tissue, alveolar lavage fluid, and other clinical tissue specimens) ; ? Molecular biological methods : clinical aseptic specimens are positive for polymerase chain reaction ( qPCR ) ; ? Antigen detection : T.marneffei specific MP1P antigen was positive ; ? Pathological diagnosis of Talaromyces marneffei. (4)Voriconazole is administered intravenously and the blood concentration of voriconazole is determined at least once.

Exclusion criteria

Exclusion criteria: (1) pregnant women or lactating women ; (2)Liver dysfunction ( baseline values of ALT and AST were 5 times higher than the upper limit of normal values) ; (3) Severe renal insufficiency or requiring hemodialysis ( creatinine clearance rate < 30 ) ; (4) Combined with other systemic fungal infections ( Cryptococcus, Candida bacteremia or Mucor infection ) ; (5) Patients diagnosed with tuberculosis and undergoing anti-tuberculosis treatment ; (6) The combination of drugs seriously affected the metabolism of voriconazole ( rifampicin, rifabutin, rifapentine, etc. ) ; (7) Patients received systemic antifungal therapy for 48 hours or more before randomization. (8) clinical data and data missing or incomplete ; (9)Allergic to voriconazole.

Design outcomes

Primary

MeasureTime frame
plasma concentration;Talaromycosis marneffei colony forming units (cfu) count;quantity of Talaromycosis marneffei-DNA;

Secondary

MeasureTime frame
minimal inhibitory concentration(MIC);

Countries

China

Contacts

Public ContactLiu Taotao

The First Affiliated Hospital of Guangxi Medical University

liutaotao@gxmu.edu+86 771 535 6789

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026