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NCT ID: NCT06433128 Available - Clinical trials for Invasive Fungal Infections

Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections

Start date: n/a
Phase:
Study type: Expanded Access

The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

NCT ID: NCT06383611 Available - Clinical trials for Prosthetic-joint Infection

Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty

APEX-EAP
Start date: n/a
Phase:
Study type: Expanded Access

The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives.

NCT ID: NCT05897294 Available - Clinical trials for Invasive Pulmonary Aspergillosis

Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

Start date: n/a
Phase:
Study type: Expanded Access

Voriconazole Inhalation Powder is available on an expanded access basis to patients with pulmonary aspergillosis for up to 12 weeks. Duration of treatment may be extended on a case-by-case basis depending on drug availability and after discussion with the Sponsor.

NCT ID: NCT04682834 Available - Clinical trials for Acute Pyelonephritis

Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection

Start date: n/a
Phase:
Study type: Expanded Access

Sulopenem etzadroxil/probenecid is available to clinicians through an Expanded Access Program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. The investigational product may be requested by sending an email to the Sponsor (EAProgram@iterumtx.com), as listed on the Reagan Udall EAP Navigator website (https://navigator.reaganudall.org/company-directory/i).

NCT ID: NCT04334070 Available - Clinical trials for Non-Tuberculous Mycobacterial (NTM) Infections

Lamprene Multiple Patient Program

Start date: n/a
Phase:
Study type: Expanded Access

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

NCT ID: NCT03786900 Available - Clinical trials for Recurrent Clostridium Difficile Infection

Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

Start date: n/a
Phase:
Study type: Expanded Access

The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor. Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.