Completed
Oral 566C80 for Severe PCP Intolerant to TMX/SMX and Pentamidine
What is being tested
Atovaquone
Drug
Who is being recruted
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This clinical trial focuses on providing a treatment option for patients with severe Pneumocystis carinii pneumonia (PCP), a type of pneumonia caused by a fungus. Specifically, it targets those who do not respond well or have negative reactions to the usual treatments, trimethoprim / sulfamethoxazole (TMX / SMX) and parenteral pentamidine. The study aims to offer these patients a new oral medication called atovaquone (566C80). The importance of this study lies in its potential to provide a much-needed alternative for patients who are struggling with current treatment options for severe PCP.
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromePneumonia, PneumocystisHIV Infections
Criteria
3 inclusion criteria required to participate
Clinical diagnosis of acute severe Pneumocystis carinii pneumonia (PCP)
Dose-limiting intolerance to TMP / SMX and parenteral pentamidine
Willingness and ability to give informed consent
2 exclusion criteria prevent from participating
History of serious dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug
Patients with a history of intolerance to 566C80
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center