NCT00002283CompletedNot Applicable
Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients
Jacobus Pharmaceutical2 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
Brief Summary
Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP / PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exclusion Criteria
- •Concurrent Medication:
- •Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).
- •Patients with the following are excluded:
- •History of allergic reaction to dapsone.
- •Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).
- •Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.
- •Prior Medication:
- •Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).
- •Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.
- •Hospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain.
- •Patients must:
- •Be willing and able to give informed consent.
- •Be expected to survive 1 week without therapy.
- •Have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this episode.
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 3
A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or SulfonamidesPneumonia, Pneumocystis CariniiHIV InfectionsNCT00000802National Institute of Allergy and Infectious Diseases (NIAID)700
Completed
Phase 1
3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00079014National Cancer Institute (NCI)36
Unknown
Phase 3
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)Postoperative IleusNCT01863407Beijing Bozhiyin T&S Co., Ltd.480
Completed
Phase 3
Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary DysplasiaBronchopulmonary DysplasiaNCT00004785National Center for Research Resources (NCRR)54
Recruiting
Phase 3
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric PopulationCataracts InfantileNCT05724446Salvat60