Search / Trial NCT00000722

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 09, 2024

Completed

Keywords

Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Pentamidine Injections, Intravenous Lung Administration, Inhalation Aerosols Acquired Immunodeficiency Syndrome

ClinConnect 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 o...

Gender

ALL

Eligibility 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

Trial Officials

Smaldone GC

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Stony Brook, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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