Nontuberculous Mycobacterial Lymphadenitis.Phase 3NCT01614977
Comparison of Antibiotic Therapy Alone or Combined With Corticosteroids for the Treatment of Nontuberculous Mycobacterial Cervicofacial Lymphadenitis in Children: A Randomized Double-Blind Placebo-Controlled Study
A Phase 3 study testing Methylprednisoline in people with Nontuberculous Mycobacterial Lymphadenitis., run by Rabin Medical Center.
Trial summary
Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections of lymph nodes in the neck and face of otherwise healthy children. There are currently 3 strategies to manage these infections. Yet, all are not "ideal" and each has downsides. 1. Read more about this study
- Who is it for?
- Ages 3 months to 20 years
- Conditions the study is for
- Nontuberculous Mycobacterial Lymphadenitis.
- What is being tested?
- Methylprednisoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to May 2014
- Phase
- Phase 3
- 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 3 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children aged 3 months to 20 years treated for laboratory-proven subacute/chronic NTM lymphadenitis.
Who cannot join
- congenital or acquired immunodeficiency
- chronic disease, such as diabetes mellitus, chronic renal failure, chronic liver disease, inflammatory bowel disease, or chronic arthritis
- immunosuppressive drug use (except inhaled steroids)
- elevated hepatocellular enzyme levels (more than twice the upper limit of normal)
- clinical suspicion of tuberculosis or a first-degree relative with tuberculosis.
About this study
Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections of lymph nodes in the neck and face of otherwise healthy children.
There are currently 3 strategies to manage these infections. Yet, all are not "ideal" and each has downsides.
Read more
- Surgery: removal of the affected lymph nodes is the most common approach but has the disadvantages of potential facial nerve paralysis, the possibility of recurrent infection that would require another operation and resolution with a cosmetically disturbing scar.
- Antibiotics: The antibiotic courses are prolonged and are associated frequently with adverse reactions. It is unclear if this treatment has a significant effect on the "natural" resolution process of the infection.
- Observation: follow-up the healing process without intervention. However the resolution may last a long period of time even more than a year. In almost all cases there will be spontaneous discharge of pus from the involved lymph nodes onto the skin that may last a few days. Later on a scar will form that may also be disturbing cosmetically.
The inflammatory response of the body to infections may occasionally be severe. As a matter of fact its harmful consequences can be sometimes more serious than those of the bacteria that cause the infection. Prednisone and other anti inflammatory drugs have properties that could possibly prevent this.
There is medical experience in using prednisone and similar drugs in addition to antibiotics in infectious diseases to decrease the inflammatory response against the infection. One of these infections is tuberculosis. The tuberculous bacteria have some common features with the nontuberculous mycobacteria. The investigators believe that the inflammatory process in infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge from the skin which later leads to the formation of a scar and to the prolonged resolution from the infection. Thus in order to hasten the resolution and to avoid formation of a neck or facial scar with its cosmetic consequences we suggest the use of prednisone in treating nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the inflammatory process as well as the immunity response, we chose to study the effect of prednisone combined with antibiotics (as the later will help to overcome the bacteria).
The purpose of the study is to determine whether the addition of prednisone to antibiotic treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of children can hasten the resolution process and improve its cosmetic results.
The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained from the involved lymph nodes by fine needle aspiration.
Generally healthy children with evidence of infection will be offered to participate in the study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:
- Antibiotics (2 types) and prednisone.
- Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but does not have any medical effect).
Prednisone will be given in a dose that will decrease into half twice: after 2 and after four weeks.
Follow-up visits for monitoring the inflammatory process and its resolution as well as adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after beginning therapy,
Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests will be also taken at the first follow-up visit.
A photo of the face neck and the site of the involved lymph nodes will be taken before starting therapy and at each of the follow-up visit.
Read the detailed description
The objective of the study is to compare the effect of antimyocbacterial therapy alone or combined with corticosteroids for the treatment of NTM lymphadenitis in children.
The study will be conducted over a 3-year period in the Day Hospitalization Unit and ward C of the Schneider Children's Medical Center of Israel using a double- blind placebo-controlled design.
Eighty children aged 3 months to 20 years treated for laboratory-proven subacute/chronic NTM lymphadenitis at the Schneider Children's Medical Center of Israel will be enrolled in the study.
Children with any of the following findings will be excluded:
- congenital or acquired immunodeficiency
- chronic disease, such as diabetes mellitus, chronic renal failure, chronic liver disease, inflammatory bowel disease, or chronic arthritis
- immunosuppressive drug use (except inhaled steroids)
- elevated hepatocellular enzyme levels (more than twice the upper limit of normal) --- clinical suspicion of tuberculosis or a first-degree relative with tuberculosis.
- Being tested
- Methylprednisoline
- Keywords
- nontuberculous mycobacteria, corticosteroids, children, lymphadeniti, Therapeutic intervention in immunocompetent children with nontuberculous mycobacterial lymphadenitis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylprednisolineDrug
Methylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days,
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | 1. Clarithromycin 15mg/Kg/day divided into 2 doses for 28 days.
2. Rifambutin 20mg/Kg/day divided into 2 doses for 28 days.
3. Methylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days. Receives: Drug: Methylprednisoline |
| Placebo | No intervention | 1. Clarithromycin 15mg/Kg/day divided into 2 doses for 28 days. 2. Rifambutin 20mg/Kg/day divided into 2 doses for 28 days. 3. placebo pills with an identical outward appearance and volume prescribed according to the same schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution process of the involved lymph nodes
The primary end points of the study will be the color of the overlying skin, lymph node consistency, formulation of a fistula, and lesion area at the second and third follow-up visits.
Measured: 3 years
Secondary outcomes (1)
Adverse reaction to the medication
The secondary end point will be any adverse reaction to the medication
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Technical problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial Lymphadenitis.Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yishai Haimi Cohen, MD, Principal investigator, SCMCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614977
- Sponsor's protocol ID
- 6570
- Status last verified
- Aug 2011
- First submitted
- 6 Jun 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antibiotic Therapy Alone or Combined With Corticosteroids for the Treatment of Nontuberculous Mycobacterial Cervicofacial Lymphadenitis in Children: A Randomized Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01614977
- Acronym / sponsor ID
- 6570
- Keywords
- nontuberculous mycobacteria, corticosteroids, children, lymphadeniti, Therapeutic intervention in immunocompetent children with nontuberculous mycobacterial lymphadenitis.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Jun 2012 (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.
Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections of lymph nodes in the neck and face of otherwise healthy children.
There are currently 3 strategies to manage these infections. Yet, all are not "ideal" and each has downsides.
- Surgery: removal of the affected lymph nodes is the most common approach but has the disadvantages of potential facial nerve paralysis, the possibility of recurrent infection that would require another operation and resolution with a cosmetically disturbing scar.
- Antibiotics: The antibiotic courses are prolonged and are associated frequently with adverse reactions. It is unclear if this treatment has a significant effect on the "natural" resolution process of the infection.
- Observation: follow-up the healing process without intervention. However the resolution may last a long period of time even more than a year. In almost all cases there will be spontaneous discharge of pus from the involved lymph nodes onto the skin that may last a few days. Later on a scar will form that may also be disturbing cosmetically.
The inflammatory response of the body to infections may occasionally be severe. As a matter of fact its harmful consequences can be sometimes more serious than those of the bacteria that cause the infection. Prednisone and other anti inflammatory drugs have properties that could possibly prevent this.
There is medical experience in using prednisone and similar drugs in addition to antibiotics in infectious diseases to decrease the inflammatory response against the infection. One of these infections is tuberculosis. The tuberculous bacteria have some common features with the nontuberculous mycobacteria. The investigators believe that the inflammatory process in infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge from the skin which later leads to the formation of a scar and to the prolonged resolution from the infection. Thus in order to hasten the resolution and to avoid formation of a neck or facial scar with its cosmetic consequences we suggest the use of prednisone in treating nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the inflammatory process as well as the immunity response, we chose to study the effect of prednisone combined with antibiotics (as the later will help to overcome the bacteria).
The purpose of the study is to determine whether the addition of prednisone to antibiotic treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of children can hasten the resolution process and improve its cosmetic results.
The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained from the involved lymph nodes by fine needle aspiration.
Generally healthy children with evidence of infection will be offered to participate in the study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:
- Antibiotics (2 types) and prednisone.
- Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but does not have any medical effect).
Prednisone will be given in a dose that will decrease into half twice: after 2 and after four weeks.
Follow-up visits for monitoring the inflammatory process and its resolution as well as adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after beginning therapy,
Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests will be also taken at the first follow-up visit.
A photo of the face neck and the site of the involved lymph nodes will be taken before starting therapy and at each of the follow-up visit.
Detailed description
The objective of the study is to compare the effect of antimyocbacterial therapy alone or combined with corticosteroids for the treatment of NTM lymphadenitis in children.
The study will be conducted over a 3-year period in the Day Hospitalization Unit and ward C of the Schneider Children's Medical Center of Israel using a double- blind placebo-controlled design.
Eighty children aged 3 months to 20 years treated for laboratory-proven subacute/chronic NTM lymphadenitis at the Schneider Children's Medical Center of Israel will be enrolled in the study.
Children with any of the following findings will be excluded:
- congenital or acquired immunodeficiency
- chronic disease, such as diabetes mellitus, chronic renal failure, chronic liver disease, inflammatory bowel disease, or chronic arthritis
- immunosuppressive drug use (except inhaled steroids)
- elevated hepatocellular enzyme levels (more than twice the upper limit of normal) --- clinical suspicion of tuberculosis or a first-degree relative with tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisoline1. Clarithromycin 15mg/Kg/day divided into 2 doses for 28 days. 2. Rifambutin 20mg/Kg/day divided into 2 doses for 28 days. 3. Methylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days. |
| Placebo | No intervention | –1. Clarithromycin 15mg/Kg/day divided into 2 doses for 28 days. 2. Rifambutin 20mg/Kg/day divided into 2 doses for 28 days. 3. placebo pills with an identical outward appearance and volume prescribed according to the same schedule. |
Who may qualify
- Ages
- 3 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children aged 3 months to 20 years treated for laboratory-proven subacute/chronic NTM lymphadenitis.
Key exclusion criteria (5 listed)
- congenital or acquired immunodeficiency
- chronic disease, such as diabetes mellitus, chronic renal failure, chronic liver disease, inflammatory bowel disease, or chronic arthritis
- immunosuppressive drug use (except inhaled steroids)
- elevated hepatocellular enzyme levels (more than twice the upper limit of normal)
- clinical suspicion of tuberculosis or a first-degree relative with tuberculosis.
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 |
|---|---|---|
| MethylprednisolineMethylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days, | Drug | Methylprednisolone |
Primary outcome
Resolution process of the involved lymph nodes
Time frame: 3 years
The primary end points of the study will be the color of the overlying skin, lymph node consistency, formulation of a fistula, and lesion area at the second and third follow-up visits.
1 secondary outcome
Adverse reaction to the medication
Time frame: 3 years.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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.
Yishai Haimi Cohen, MD principal investigator
SCMCI
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisoline in people with Nontuberculous Mycobacterial Lymphadenitis., run by Rabin Medical Center.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Resolution process of the involved lymph nodes (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 2 Dec 2014.