Completed

Atovaquone (566C80) for Mild to Moderate Pneumocystis Carinii Pneumonia in Intolerant/Unresponsive Patients

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What is being tested

Atovaquone

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

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 called atovaquone (566C80) to patients suffering from mild to moderate Pneumocystis carinii pneumonia (PCP), a type of lung infection. The study is designed for patients who do not respond well or are intolerant to the standard treatment using trimethoprim / sulfamethoxazole (TMP / SMX). The main goal is to offer an alternative treatment option for these patients, aiming to improve their condition and address the unmet need for effective therapies in such cases. During the study, participants receive atovaquone (566C80) as their treatment. The study keeps track of any serious side effects that might be linked to this drug. This way, the researchers can monitor its safety and effectiveness for future use in patients with similar conditions.

NCT00001991
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 mild to moderate Pneumocystis carinii pneumonia
Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX
Willingness and ability to give informed consent
1 exclusion criteria prevent from participating
History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug

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

Glaxo Wellcome Inc

Research Triangle Park, United StatesOpen Glaxo Wellcome Inc in Google Maps
CompletedOne Study Center