Improving Care Through Azithromycin Research for Infants in Africa
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
The goal of this project is to improve child survival in areas with high mortality rate.
The specific objectives are:
Primary:
1. To assess the effect on all-cause mortality up to 18 months of age of AZi administration at 6 weeks and 9 months of age alongside routine EPI immunisations
2. To determine the effect on all-cause mortality up to 18 months of age of AZi administration at 6 weeks, 9 and 15 months of age alongside routine EPI immunisations
3. To evaluate the safety of repeated AZi administration through the EPI
4. To contribute to the capacity building of young African researchers
5. To catalyse research synergies between European and African countries to tackle poverty-related diseases
Secondary:
1. To evaluate the effect on all-cause mortality up to 18 months of age of an additional dose of AZi at 15 months of age
2. To evaluate the effect on all-cause mortality of an additional dose of IPTi at 15 months of age
3. To assess the potential development of resistance to macrolides
4. To assess the impact on gut microbiota
5. To evaluate the potential interaction with routine EPI immunisations (measles and yellow fever)
6. To examine the health system implications of the addition of AZi to the EPI and its acceptability by health providers and participants
Ημερομηνίες
| Τελευταία επαλήθευση: | 12/31/2019 |
| Πρώτα υποβλήθηκε: | 01/16/2020 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 01/16/2020 |
| Δημοσιεύτηκε για πρώτη φορά: | 01/21/2020 |
| Υποβλήθηκε τελευταία ενημέρωση: | 01/21/2020 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 01/26/2020 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 04/30/2020 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 07/31/2024 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 12/29/2024 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Azithromycin
Drug: Sulphadoxine-pyrimethamine
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Placebo Comparator: Group 1 AZi at Penta-1 visit, IPTi-SP at Penta-2 and Penta-3 visits, AZi plus IPTi-SP at measles visit at 9 months of age and placebo-placebo at measles visit at 15 months of age | |
| Active Comparator: Group 2 AZi at Penta-1 vaccine visit, IPTi-SP at Penta-2 visit and Penta-3 visit, AZi plus IPTi-SP at measles 1 visit and AZi plus IPTi-SP at measles 2 visit at 15 months of age | |
| Placebo Comparator: Group 3 Placebo at Penta-1 visit, IPTi-SP at Penta-2 and Penta-3 visits, placebo plus IPTi-SP at measles visit at 9 months of age and placebo-placebo at measles visit at 15 months of age | |
| Placebo Comparator: Group 4 Placebo at Penta-1 visit, IPTi-SP at Penta-2 and Penta-3 visits, placebo plus IPTi-SP at measles visit at 9 and at 15 months of age |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 6 Weeks Προς την 6 Weeks |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - Parents/guardians have signed the informed consent - Permanent residence in the study area-health facility catchment area - Without known allergies to or contraindications to macrolides - Without known allergies to or contraindications to SP - Agreement to complete the EPI scheme at the recruitment health facility - Parents/guardians agree to participate Exclusion Criteria: - Residence outside the study area or planning to move out in the following 12 months from enrolment - Known history of allergy or contraindications to macrolides and/or SP - Known history of allergy or contraindications to SP - With signs of any acute illness at the time of recruitment - Participating in other intervention studies |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. The rate of all-cause mortality [18 months of age]
Δευτερεύοντα αποτελέσματα
1. The cause-specific mortality rate [18 months of age]
2. Malaria related mortality [18 month of age]
3. Incidence of all-cause hospital admissions [36 months]
4. Incidence of confirmed (RDT positive) malaria outpatient attendances [36 months]
5. Incidence of confirmed (blood smear positive) malaria hospital admissions [36 months]
6. Frequency and severity of drug adverse reactions [36 months]
7. Prevalence of SP resistance in U5 children [36 months]
8. Prevalence of macrolide resistance in nasopharyngeal isolates [36 months]
9. Prevalence of macrolide resistance in the gut bacteria [36 months]
10. The proportion of children with protective antibody responses to specific routine EPI immunisations (measles and yellow fever) [36 months]
