Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
Data Collection
Blood-Borne Infections+28
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Aerosolized pentamidine was as effective as intravenous pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less was found in the liver and kidney after pentamidine was given by aerosol than after an intravenous injection. This suggests that the toxicity of pentamidine may be less if given by aerosol than if given by the intravenous route. Patients will inhale one dose of radiolabeled aerosol containing pentamidine, and an image of the lung will be taken immediately and then 24 hours later to determine the amount of pentamidine reaching the various areas of the lung. Patients will then undergo a bronchoalveolar lavage (BAL) in order to recover the PCP organism from the lung and to corroborate the diagnosis of PCP. If PCP organisms are detected, patients will be randomly assigned to aerosolized or intravenous pentamidine and treated for 21 days. Patients taking pentamidine by aerosol will repeat the radiolabeled aerosol study on day 9. The BAL will be repeated at the end of therapy for all patients. If patients do not improve within 9 days, they will be switched to another therapy. After completion of therapy, patients will be given the option of prophylactic therapy, i.e., doses of medication to prevent reinfection, for PCP. All patients will be carefully assessed every 4 weeks for 6 months whether they begin prophylactic therapy or not. Zidovudine (AZT) may not be taken during the 21-day trial because of the increased risk of side effects, but it can be resumed when PCP therapy is completed.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
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
Criteria
Inclusion Criteria Prior Medication: Allowed: * Prophylaxis for Pneumocystis carinii pneumonia (PCP); zidovudine. Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) established by morphological confirmation of three or more typical Pneumocystis carinii organisms in bronchoalveolar lavage fluid, obtained immediately following the initial inhalation of radiolabeled aerosol. * Resting (A-a) DO2 \< 30 torr on room air or resting (A-a) DO2 = or \< 55 torr on room air with a serious intolerance to trimethoprim / sulfamethoxazole (TMP / SMX), defined as one or more of the following: * Platelets \< 50000 platelets/mm3 or absolute neutrophil count (polys plus bands) = or \< 500 cells/mm3 on at least two occasions = or \> 12 hours apart. * Blistering rash, mucosal involvement, generalized maculopapular eruption, or intolerable pruritus. * Transaminase \> 5 x ULN or = or \> 300 IU if baseline is abnormal. * Daily temperature = or \> 103 degrees F beginning after the 5th day of treatment and persisting for at least 3 days and not responsive to antipyretic therapy, with no other discernible cause. * Any other severe or life-threatening adverse reaction to TMP / SMX that, in the investigator's opinion, makes continued or recurrent treatment with TMP / SMX inadvisable (approved on a case-by-case basis by the NIAID clinical monitor). Exclusion Criteria Co-existing Condition: Patients with the following conditions or diseases are excluded: * Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. * History of major adverse reaction to pentamidine. Patients with the following conditions or diseases are excluded: * Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. * History of major adverse reaction to pentamidine. Prior Medication: Excluded: * Other antiprotozoal regimens. * Excluded within 14 days of entry: * Systemic steroids \> adrenal replacement doses
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