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Completed

NCT Number: NCT05642624

The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock

To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis and septic shock.

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, Nanjing, Jiangsu, China

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About this study

This was a single-center study.Patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin B during the study period.The information was recored including the general condition, infection index, PK/PD index and drug-related side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients age more than 18 years old; Meet the criteria of Sepsis 3.0; Admitted to ICU; Patients were suspected or diagnosis of IFI,doctors determined the use of deoxycholic acid amphotericin B.

Exclusion criteria

Serum creatinine≥221umol/L; Deoxycholic acid amphotericin B or amphotericin B liposome were used for the past 7 days; Patients being treated with rifampicin; Unable to tolerate treatment of deoxycholic acid amphotericin B; BMI<18.5 or >30; Tumors; Pregnancy; Estimated time of survival<24h; Patients who participated in other studies within 30 days.

Treatment and study plan

Deoxycholic acid amphotericin B

Drug

Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.

Other names: amphotericin B

Primary outcomes

  1. Cmax/MIC

    Time frame: 14 days

    PK/PD of Deoxycholic Acid Amphotericin B

Secondary outcomes

  1. AUC24h/MIC

    Time frame: 14 days

    Concentration of Deoxycholic Acid Amphotericin B

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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