TuberculosisNCT00512330
Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)
An observational study of Tuberculosis, run by University Hospital, Bonn at 1 site in Malawi.
Trial summary
In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 250 participants
- Where
- 1 siteMalawi
- Study dates
- Aug 2007to Aug 2008
- Phase
- Observational
- 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 Up to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children up to 14 years of age with suspicion of TB
Who may be able to join
- age 0-14 years
- suspicion of active TB or TB contact
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
John Chimphamba, Clinical Officer contact
Malawi1 site, 1 recruiting
- Recruiting
Our Lady of Mount Carmel Hospital
Kapiri/Mchinji, Mchinji
John Chimphamba, Clinical Officer
About this study
Official title: Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults.
Our study aims to evaluate this test in the diagnosis of children with TB.
Read the detailed description
Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005).
Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.
- Conditions
- Tuberculosis
- Keywords
- childhood, tuberculosis, diagnostic, lipoarabinomannan, ELISA, Tuberculosis in Childhood
- Medical subject headings
- Tuberculosis, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startAug 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi, Ministry of Health, Malawi, Mbeya Medical Research Programme, Mbeya, Tanzania, Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany, Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany, Children's Medical Hospital, University of Bonn, Germany
- Investigators
- Norbert Heinrich, MD, Study chair, University of BonnJohn Chimphamba, Clinical Officer, Principal investigator, Our Lady of Mount Carmel Hospital, KapiriAndreas Mueller, PD Dr med., Study chair, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512330
- Sponsor's protocol ID
- LAM ELISA in childhood TB
- Status last verified
- Aug 2008
- First submitted
- 6 Aug 2007
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
- ClinicalTrials.gov ID
- NCT00512330
- Acronym / sponsor ID
- LAM ELISA in childhood TB
- Conditions
- Tuberculosis
- Keywords
- childhood, tuberculosis, diagnostic, lipoarabinomannan, ELISA, Tuberculosis in Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi, Ministry of Health, Malawi, Mbeya Medical Research Programme, Mbeya, Tanzania, Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany, Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany, Children's Medical Hospital, University of Bonn, Germany
- Study start
- Aug 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 7 Aug 2007 (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.
In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults.
Our study aims to evaluate this test in the diagnosis of children with TB.
Detailed description
Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005).
Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children up to 14 years of age with suspicion of TB
Key inclusion criteria (2 listed)
- age 0-14 years
- suspicion of active TB or TB contact
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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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.
John Chimphamba, Clinical Officer contact
Norbert Heinrich, MD study chair
University of Bonn
John Chimphamba, Clinical Officer principal investigator
Our Lady of Mount Carmel Hospital, Kapiri
Andreas Mueller, PD Dr med. study chair
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University Hospital, Bonn at 1 site in Malawi.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 2008. 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 Malawi. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norbert Heinrich, MD (0049 179 7044231, norbert.heinrich@ukb.uni-bonn.de), or a site near the patient. 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 6 Aug 2008.