Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583512
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Treatment Duration of IPA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Invasive Pulmonary Aspergillosis Treatment Duration of Posaconazole-initiated Antifungal Strategy in Patients with Hematological Malignancies a Prospective Single-center Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to identify the duration of posaconazole-initiated antifungal treatment for IPA in patients with hematological malignancies and to explore the value of monitoring immune factors and cells in IPA treatment in order to assess practices in IPA management in Chinese hematology patients including tools to evaluate duration and discontinuation The main question it aims to answer is
Does any indicators that could be used to guide the duration of IPA treatment Does immune factors have value in monitoring IPA treatment We will not do any interventions to participants Participants will be monitored routinely for their clinical characteristics microbiological test including GGM Test Blood culture Imaging examination Blood routine the number and function of immune cells cytokinesIL-1βIL-2IL-4IL-8IL-10IL-12IL-17IFN-αIFN-γTNF-α and we will collect these datas for analysing
Does any indicators that could be used to guide the duration of IPA treatment Does immune factors have value in monitoring IPA treatment We will not do any interventions to participants Participants will be monitored routinely for their clinical characteristics microbiological test including GGM Test Blood culture Imaging examination Blood routine the number and function of immune cells cytokinesIL-1βIL-2IL-4IL-8IL-10IL-12IL-17IFN-αIFN-γTNF-α and we will collect these datas for analysing
Detailed Description:
1 A total of 15 patients will be involved in the study
2 For each patient the investigator will first evaluate the patient to determine if the patient meets the enrollment criteria and does not meet any of the exclusion criteria
3 For the patients included in the study the investigators will collect their blood RT immune cell count and function and cytokine levels including IL-1βIL-2IL-4IL-5IL-6IL-8IL-10IL-12IL-17INF-γINF-αTNF-α et al
4 Closely monitor the patients status and discontinue antifungal therapy if the patient meet the 4 critera ①PMNs recovery500②previous signssymptoms of active IPA such as fever has been resolved ③nagative mycological evidence ④CT the reduction in the size of the lesion must exceed 90 or stable cave If the patient does not meet any of these criteria antifungal therapy is continued until the 4 critera are met
5 Blood RT neutrophil count and function and cytokine levels IL-1βIL-2IL-4IL-5IL-6IL-8IL-10IL-12IL-17INF-γINF-αTNF-α were collected at the time of stopping antifungal therapy and at 2 4 8 and 12 weeks after stopping treatment At the same time the patients symptoms cough hemoptysis fever etc and signs chest pain etc were observed and the patients microbiology examination results blood GGM text fungal culture etc and imaging examination results CT etc were collected at the follow-up
6 Follow-up will be conducted instantly if any symptom sign or text result suspected IPA after discontinuation
2 For each patient the investigator will first evaluate the patient to determine if the patient meets the enrollment criteria and does not meet any of the exclusion criteria
3 For the patients included in the study the investigators will collect their blood RT immune cell count and function and cytokine levels including IL-1βIL-2IL-4IL-5IL-6IL-8IL-10IL-12IL-17INF-γINF-αTNF-α et al
4 Closely monitor the patients status and discontinue antifungal therapy if the patient meet the 4 critera ①PMNs recovery500②previous signssymptoms of active IPA such as fever has been resolved ③nagative mycological evidence ④CT the reduction in the size of the lesion must exceed 90 or stable cave If the patient does not meet any of these criteria antifungal therapy is continued until the 4 critera are met
5 Blood RT neutrophil count and function and cytokine levels IL-1βIL-2IL-4IL-5IL-6IL-8IL-10IL-12IL-17INF-γINF-αTNF-α were collected at the time of stopping antifungal therapy and at 2 4 8 and 12 weeks after stopping treatment At the same time the patients symptoms cough hemoptysis fever etc and signs chest pain etc were observed and the patients microbiology examination results blood GGM text fungal culture etc and imaging examination results CT etc were collected at the follow-up
6 Follow-up will be conducted instantly if any symptom sign or text result suspected IPA after discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None