CryptosporidiosisNCT00002328
Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
A study testing Azithromycin in people with Cryptosporidiosis and HIV Infections, run by Pfizer at 1 site in United States.
Trial summary
To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Azithromycin
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Cryptosporidiosis infection.
- Life expectancy of at least 1 week.
- Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
- Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.
- Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
- Required:
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy
To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Azithromycin
- Keywords
- Antidiarrheals, Cryptosporidiosis, Diarrhea, Acquired Immunodeficiency Syndrome, Azithromycin
- Medical subject headings
- Cryptosporidiosis, HIV Infections, Diarrhea, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
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.
- Other trials for CryptosporidiosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002328
- Sponsor's protocol ID
- 058J
- Other IDs
- 066-167S
- Status last verified
- Jul 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy
- ClinicalTrials.gov ID
- NCT00002328
- Acronym / sponsor ID
- 058J
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- Antidiarrheals, Cryptosporidiosis, Diarrhea, Acquired Immunodeficiency Syndrome, Azithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (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 provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Cryptosporidiosis infection.
- Life expectancy of at least 1 week.
- Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
- Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.
- Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.
Key exclusion criteria (6 listed)
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
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 |
|---|---|---|
| Azithromycin | 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.
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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 Azithromycin in people with Cryptosporidiosis and HIV Infections, run by Pfizer 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 6 inclusion and 6 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?
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.