Trial · NCT02426112
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forced Expiratory Volume in one second z score (FEV1) | 12 months | Change in FEV1after 12 months of initiation of therapy with azithromycin |
| Secondary | Forced Expiratory Volume in one second z score (FEV1) | 24 months | Mean change in FEV1 24 months after treatment initiation with azithromycin |
| Secondary | Time to death | 12 months | Time to death 12 months after treatment initiation with azithromycin |
| Secondary | Time to first acute exacerbation | 12 months | |
| Secondary | Number of hospitalizations | 12 and 24 months | |
| Secondary | Number of exacerbations | 12 and 24 months | |
| Secondary | Quality of life scores | 12 and 24 months | |
| Secondary | Mean change in weight-for-age z-score | 12 and 24 months | |
| Secondary | Number of mild, moderate and severe adverse events | 12 months | |
| Secondary | Number of Malaria episodes (Malawi only) | 12 months | |
| Secondary | Number of blood stream infections due to Salmonella typhi and non-typhi | 12 months | |
| Secondary | Number of gastroenteritis episodes | 12 months | |
| Other | Macrolide resistance | 12 months | Prevalence of colonization with macrolide (and multidrug-resistant) Streptococcus pneumoniae, Staphylococcus aureus and Haemophilus influenzae in the two trial arms at 12 months of initiation of treatment with azithromycin |
| Other | Lung microbiome | baseline, 12 and 14 months | Composition and diversity of the respiratory bacterial microbiome (determined by culture of clinically relevant organisms and sequencing of 16s rRNA gene amplicons) |
| Other | Gut microbiome | baseline, 12 and 24 months | Composition and diversity of the gut bacterial microbiome (determined by culture of clinically relevant organisms and sequencing of 16s rRNA gene amplicons |
| Other | Inflammation biomarkers | baseline, 12 and 24 months | Association between inflammation biomarker levels and FEV1 |
| Other | Cardiac dysfunction | Baseline | prevalence of right sided cardiac dilatation and dysfunction |
| Other | Cardiac dysfunction after treatment | 12 and 24 months | Prevalence of right sided cardiac dilatation and dysfunction at 12 and 24 months of initiation of azithromycin therapy by intervention arm |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02426112/registered