Pneumonia, Pneumocystis CariniiNCT00002292
A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
A study testing Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by LyphoMed at 1 site in United States.
Trial summary
To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Pentamidine isethionate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Previous history of adverse reaction to pentamidine.
- History of asthma.
- Pulmonary Kaposi's sarcoma.
- Patients with the following are excluded:
Show all 12Show fewer
- Previous history of adverse reaction to pentamidine.
- History of asthma.
- Pulmonary Kaposi's sarcoma.
- Inability to understand the consent procedure.
- All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible.
- Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaled Versus Intravenous Pentamidine in Pneumocystis Carinii Pneumonia in the Acquired Immunodeficiency Syndrome
To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Pentamidine isethionate
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Injections, Intravenous, Administration, Inhalation, Aerosols, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, AIDS-Related Opportunistic Infections, Respiratory Aspiration, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentamidine isethionateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- LyphoMed
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002292
- Sponsor's protocol ID
- 023B
- Other IDs
- 88-001
- Status last verified
- Aug 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Soo Hoo GW, Mohsenifar Z, Meyer RD. Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):195-202. doi: 10.7326/0003-4819-113-3-195.
PubMed 2197910Conte JE Jr, Chernoff D, Feigal DW Jr, Joseph P, McDonald C, Golden JA. Intravenous or inhaled pentamidine for treating Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):203-9. doi: 10.7326/0003-4819-113-3-203.
PubMed 2197911
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Versus Intravenous Pentamidine in Pneumocystis Carinii Pneumonia in the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002292
- Acronym / sponsor ID
- 023B
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Injections, Intravenous, Administration, Inhalation, Aerosols, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- LyphoMedIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Previous history of adverse reaction to pentamidine.
- History of asthma.
- Pulmonary Kaposi's sarcoma.
- Previous history of adverse reaction to pentamidine.
- History of asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentamidine isethionate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 2197910Soo Hoo GW, Mohsenifar Z, Meyer RD. Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):195-202. doi: 10.7326/0003-4819-113-3-195.
- Background: PubMed 2197911Conte JE Jr, Chernoff D, Feigal DW Jr, Joseph P, McDonald C, Golden JA. Intravenous or inhaled pentamidine for treating Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):203-9. doi: 10.7326/0003-4819-113-3-203.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by LyphoMed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.