Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Immunosuppressed status due to: Reception of allogeneic hematopoietic stem cell transplantation after myeloablative or non-myeloablative conditioning; Malignant haematological disease (excluding participants with progressive hematological disease who have not responded (or probably do not respond) to treatment);
• Diagnosis of proven or probable or possible aspergillosis (based on a modified version of the revised EORTC / MSG consensus definitions, see Annex 1);
• Men or women> 16 years of age;
• In the case of women of childbearing age, the patient has been negative in the urine pregnancy test.
• Proof of a signed and personally dated informed consent document in accordance with local legal provisions that indicate that the participant (or a legally acceptable representative) has been informed of all aspects related to the study.
• Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria

• Known history of allergy, hypersensitivity or serious reaction to azole or echinocandin antifungals;
• Patients who are pregnant or breastfeeding;
• Patients with sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA);
• Patients with chronic invasive aspergillosis with a duration of symptoms or radiological findings for more than 4 weeks before entering the study;
• Patients who are receiving and can not discontinue the use of the following drugs at least 24 hours before randomization: terfenadine, astemizole, cisapride, pimozide or quininidine (due to the possibility of QT prolongation);
• Patients receiving one of the following medications: sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates (eg phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids eg, ergotamine, dihydroergotamine);
• There are other potentially clinically relevant interactions between voriconazole and some drugs that are prescribed regularly. Although these drugs are not contraindicated, it is advisable to monitor or adjust the dosage, as described in Annex 2.
• The reception of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis.
• Severe hepatic dysfunction (defined as total bilirubin> 10x upper limit of normal, or AST, ALT, alkaline phosphatase> 5x upper limit of normal). The results of the local laboratory can be used to qualify the participants for enrollment. However, if the laboratory values obtained in the Baseline visit exceed the above limits for exclusion, the medical monitor should be contacted without delay to discuss the continuation of the study treatment;
• Patients with artificial ventilation;
• Patients with any clinical condition that, in the opinion of the investigator, may affect patient safety, impede the evaluation of the response, or make it unlikely that the proposed course of therapy can be completed;
• Patients who are receiving, or likely to receive, any Phase 1 research drug. Patients receiving Phase II or Phase III research drugs may only enroll with the prior approval of the medical monitor. Patients can be enrolled
• To receive research drugs that are currently authorized for other indications;
• Inclusion of a patient more than once in this study is not allowed;
• Patients who are not expected to survive for at least 5 days or who already have a Kamofsky score of <30
• Patients with a high probability of death due to factors unrelated to aspergillosis (for example, due to a recurrent malignancy, severe graft-versus-host disease, other underlying diseases, etc.) within 30 days after to the planned enrollment (at the investigator´s discretion);
• Another severe, acute or chronic medical or psychiatric condition or laboratory test with an abnormal result that could increase the risk associated with participation in the study or administration of investigational products or that could interfere with the interpretation of the results of the study and , in the opinion of the researcher, may make the participant unsuitable to enter this study;
• Concomitant administration of systemic agents active against Aspergillus species is not allowed.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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