CLINICAL TRIAL

Azithromycin for Mycobacterium Infections

Recruiting · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a common antibiotic may help treat a lung infection.

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About the trial for Mycobacterium Infections

Eligible Conditions
Mycobacterium Infections · Mycobacterium avium complex infection · Mycobacterium avium-intracellulare Infection

Treatment Groups

This trial involves 2 different treatments. Azithromycin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Azithromycin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azithromycin
FDA approved

Side Effect Profile for Biannual Mass Oral Azithromycin

Biannual Mass Oral Azithromycin
Show all side effects
3%
Death
0%
Malaria
0%
Coma
0%
Pneumonia
0%
ARI
0%
Unspecified
0%
Suspected dehydration
0%
Suspected ileus
0%
Diarrhea
Death
3%
Malaria
0%
Coma
0%
Pneumonia
0%
ARI
0%
Unspecified
0%
Suspected dehydration
0%
Suspected ileus
0%
Diarrhea
0%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02047981) in the Biannual Mass Oral Azithromycin ARM group. Side effects include: Death with 3%, Malaria with 0%, Coma with 0%, Pneumonia with 0%, ARI with 0%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Producing a sputum sample of at least 10mL within a 16 hour period is considered essential for a diagnosis of tuberculosis. show original
The text is asking the reader to meet the criteria set by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) for a diagnosis of Mycobacterium avium complex (MAC) lung disease. show original
The doctor plans to treat the patient for Mycobacterium avium complex lung disease. show original
Age ≥18 years
A respiratory specimen has been collected in the last 6 months from a person with a M show original
Signed informed consent by the subject
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and 2 Months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline and 2 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and 2 Months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Azithromycin will improve 1 primary outcome and 4 secondary outcomes in patients with Mycobacterium Infections. Measurement will happen over the course of Baseline and Day 14.

Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)
BASELINE AND DAY 14
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between Baseline and Day 14.
BASELINE AND DAY 14
Estimation of maximum plasma concentration (Cmax) of azithromycin
2 AND 6 HOURS POST-DOSE ON DAY 29
Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.
2 AND 6 HOURS POST-DOSE ON DAY 29
Estimation of plasma azithromycin area-under-the-curve (AUC) following oral dosing azithromycin
PRE-DOSE, 2, 4 AND 6 HOURS POST-DOSE ON DAY 15, AND 2 AND 6 HOURS POST-DOSE ON DAY 29
Area-under-the-curve (ug/mL*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.
PRE-DOSE, 2, 4 AND 6 HOURS POST-DOSE ON DAY 15, AND 2 AND 6 HOURS POST-DOSE ON DAY 29
Change in time to positivity of Mycobacterium avium growth in MGIT
BASELINE AND 2 MONTHS
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and 2 months.
BASELINE AND 2 MONTHS
Change in Mycobacterium avium colony count in sputum
BASELINE AND 2 MONTHS
The bactericidal activity of multidrug therapy for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 CFU per mL) in sputum between baseline and 2 months.
BASELINE AND 2 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of mycobacterium infections?

Mycobacterial infections are common in children. Infections of the respiratory tract are the leading sources. Rarely, mycobacterium infections occur at injection sites. In the past, mycobacterium infections might have been confused with cellulitis.

Anonymous Patient Answer

What is mycobacterium infections?

Infections with mycobacteria can present with a broad range of clinical problems. The diagnosis is reliant on an accurate clinical history and the isolation of the organism from tissue. The diagnosis of an infection associated with HIV is particularly challenging as many of the criteria used to identify mycobacterial infection in non-HIV-infected patients are similar to those used to identify mycobacterial infection in HIV patients. Treatment decisions may be informed by HIV status, whether or not antituberculous therapy is to be given, the immunologic status of the patient, and the presence or absence of disease.

Anonymous Patient Answer

What are the signs of mycobacterium infections?

Biosensors are an invaluable part of the diagnostic laboratory and can aid in the timely determination of the presence of infection by a mycobacterium organism. However, in order to be effective the use of laboratory tests can only be effective if the diagnostic process is complete and comprehensive. In many instances the diagnosis is delayed because results are sent back within the specified time frame and because the relevant diagnostic microbiology, tests and procedures are often not available in the routine pathology department. Many patients with serious infections may not have the opportunity to undergo relevant investigations.

Anonymous Patient Answer

What causes mycobacterium infections?

Infection is a very common cause of immunocompromised disease, and specific agents can vary from region to region. The common causal agent for immunocompromised disease remains M. tuberculosis.

Anonymous Patient Answer

What are common treatments for mycobacterium infections?

Most common treatments for M. tuberculosis are treatment with multiple drugs and supportive therapy. Some treatments used are antimicrobial agents like fluoroquinolones, second-line drugs, and isoniazid/rifampin.

Anonymous Patient Answer

How many people get mycobacterium infections a year in the United States?

The prevalence of M infections was 8.7% in adult populations in the United States, and the annual incidence was estimated to be approximately 20 cases per 100,000 persons. The incidence rate declined significantly in individuals age 50 and over.

Anonymous Patient Answer

Can mycobacterium infections be cured?

Mycobacterium infections are not cureable. The risk of developing recurrent mycobacterium infections and disability due to Mycobacterium infections should be kept in mind. In addition, other factors that may be responsible for developing a disability should also be considered.

Anonymous Patient Answer

Is azithromycin safe for people?

People on azithromycin appear to have an increased risk of death and severe infections, including mycobacterial infection, compared with people with similar conditions but who do not take azithromycin. The combination of macrolides may be associated with serious and in some cases fatal mycobacterial bacterial infections, especially in persons with other risk factors for infection.

Anonymous Patient Answer

What is the latest research for mycobacterium infections?

New drugs are being developed and tested, but the benefits for individuals with mycobacterium infections is that many are already available. These drugs are not approved in many countries.

Anonymous Patient Answer

What is the average age someone gets mycobacterium infections?

Patients with mycobacterium infections are often old—on average 84 years of age. Mycobacterium infections are more common among elderly patients. Infection prevalence and incidence (the number of new infections per year) appear to be increasing in the United States.

Anonymous Patient Answer

Does mycobacterium infections run in families?

Findings from a recent study indicate that a genetically determined susceptibility to mycobacteria can be found in a quarter of the offspring of parents with active cases. It is probably related to the presence of non-pulmonary and non-systemic mycobacterial infections at the time of conception. These children are more susceptible to pulmonary and systemic infections and therefore may have an increased risk to develop serious or even fatal disease.

Anonymous Patient Answer

Have there been other clinical trials involving azithromycin?

While it is unlikely that all of the patients who participated in the study would have been eligible for entry into a clinical trial, we cannot definitively rule out the possibility that the patients did not obtain adequate treatment with azithromycin. In the future, an important advance will be the ability of doctors to communicate openly with patients about clinical trials to encourage patients to enroll in and participate in clinical trials.

Anonymous Patient Answer
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