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Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.


- candidate number8427
- NTR NumberNTR2499
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2010
- Secondary IDs10/057 METC AMC
- Public TitleIs antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.
- Scientific TitleIs antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.
- ACRONYMTEXACOLD trial
- hypothesisWe postulate that antiobiotics added to corticosteroids in the treatment of exacerbations of COPD, will prolong time to next exacerbation.
- Healt Condition(s) or Problem(s) studiedCOPD, Antibiotics, Doxycycline, Exacerbation
- Inclusion criteria1. Age 45 years and older;
2. COPD GOLD 1, 2 or 3;
3. At least 1 documented exacerbation during the past 3 years;
4. Last exacerbation at least 4 weeks prior to inclusion, and symptoms returned to patientís baseline level;
5. A smoking history of at least 10 pack years.
- Exclusion criteria1. Poor cognitive functioning;
2. Poor mastering of the Dutch language;
3. Allergy for doxycyclin;
4. Pregnancy;
5. A life expectancy less than 1 month.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate1-apr-2014
- Target number of participants470
- InterventionsA cohort of 1000 participants will be collected. Target number of participants in the RCT is 470 (needed to collect 251 second exacerabations).

In case of an exacerbation, patients will be randomized between doxycyclin and placebo. Not eligible for radomization are patients who should be treated with antibiotics according to current guidelines, patients who require hospitalization, patients who currently use antibiotics and patients who used antibiotics for a respiratory tract infection in the last 3 weeks.
- Primary outcomeTime to next exacerbation.
- Secondary outcome1. Mortality during follow up;
2. Number of exacerbations during follow up;
3. Treatment failure rate at test of cure (day 21) and late follow-up (day 90);
4. Cultured microorganisms at subsequent exacerbation, and, in subgroup, during 6 months after exacerbation;
5. Health related quality of life;
6. Decline of lung volumes;
7. Total antibiotic use;
8. Costs.
- Timepoints1. At inclusion in cohort: History, clinical evaluation, sputum culture;
2. At inclusion in randomized clinical trial: History, clinical evaluation, sputum culture;
3. Follow up at week 1, 2, 3 ,4, 12, 24, 36, 48, 60, 72, 84, 96 after inclusion in randomized clinical trial.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES P. Velzen, van
- CONTACT for SCIENTIFIC QUERIES P. Velzen, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development , Grant nr 80-82310-97-10018
- PublicationsN/A
- Brief summaryChronic obstuctive pulmonary disease (COPD) is a very prevalent, chronic disease. For the majority of COPD outpatients, it is at the present not clear whether during an exacerbation antibiotics should be added to treatment with corticosteroids. On the short term, antibiotic treatment has limited added value. However, retrospective data manifest a prolonged time to the next exacerbation. The major drawback of treating all exacerbations with antibiotic, will be the significant increase in overall antibiotic consumption, which will fuel the increasing rates of resistance among respiratory pathogens. Therefore, benefits of antibiotic treatment have to be confirmed in a prospective study.
- Main changes (audit trail)19-juni-2015:

Inclusion NEW:
3. At least 1 documented or self-reported exacerbation during the past 3 years;


Interventions NEW:
A cohort of 1000 participants will be collected.

In case of an exacerbation, patients will be randomized between doxycyclin and placebo. Not eligible for randomization are patients who should be treated with antibiotics according to current guidelines, patients who require hospitalization, patients who currently use antibiotics and patients who used antibiotics for a respiratory tract infection in the last 3 weeks.

Target number of participants in the RCT is 470 (needed to collect 251 second exacerbations).
- RECORD9-sep-2010 - 19-jun-2015


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