Neonatal InfectionPhase 3PregnAnZINCT01800942
Prevention of Bacterial Infections in Newborn
A Phase 3 study of Neonatal Infection, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age. Severe bacterial disease is among the leading causes of neonatal deaths. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Infection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 829 participants
- Where
- 1 siteThe Gambia
- Study dates
- Feb 2013to Aug 2015
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women (aged 18 to 45 years)
- in labour
- attending a health centre in western Gambia for delivery
Who cannot join
- Known HIV infection.
- Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician.
- Planned travelling out of the catchment area during the following 2 months (follow-up period)
- Planned caesarean section
- Known required referral
- Known multiple pregnancy
Show all 10Show fewer
- Known severe congenital malformation
- Intrauterine death confirmed before randomization
- Known allergy to macrolides
- Consumption of antibiotic within the week before randomisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial
The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.
Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.
Read more
Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.
If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.
The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.
The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.
This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease
- Conditions
- Neonatal Infection
- Being tested
- Azithromycin and Placebo
- Keywords
- prevention, bacterial infection, neonates, women in labour, Azithromycin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin and PlaceboDrug
A single oral dose of 2g of Azithromycin will be given to the women in labour
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo.
A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour. Receives: Drug: Azithromycin and Placebo |
| Azithromycin | Experimental | 830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo.
A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour. Receives: Drug: Azithromycin and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus
The primary outcome is the prevalence of nasopharyngeal carriage of the newborn at the age of six days for any of the following bacteria: 1) Group B Streptococci, 2) S.pneumoniae and 3) S.aureus.
Measured: 6 days
Secondary outcomes (1)
Vaginal bacterial Group B Streptococci(GBS), S.pneumoniae and S.aureus) carriage at day six post-delivery. Vaginal bacterial (GBS, S.pneumoniae and S.aureus) carriage at day 8-10 post-delivery
The secondary outcomes are the prevalence of:
- Newborn's nasopharyngeal bacterial Group B Streptococci (GBS), S.pneumoniae and S.aureus) carriage at any other scheduled visit.
Bacterial isolates Group B Streptococci (GBS), S.pneumoniae and S.aureus), both from the newborn and the mother, non-susceptible to macrolides, from different study samples and time-points.
Bacterial Group B Streptococci (GBS), S.pneumoniae and S.aureus) carriage in the breast milk at any scheduled visit.
Purulent conjunctivitis within the first 4 weeks of life. Purulent Chlamydial conjunctivitis. AZI levels in breast milk on day 3 and 6 post-delivery.
Measured: 6-13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Roca, PhD, Principal investigator, Medical Research Council Unit, The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800942
- Sponsor's protocol ID
- SCC1282
- Acronym
- PregnAnZI
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2013
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jagne I, Keeley AJ, Bojang A, Camara B, Jallow E, Senghore E, Oluwalana C, Bah SY, Turner CE, Sesay AK, D'Alessandro U, Bottomley C, de Silva TI, Roca A. Impact of intra-partum azithromycin on carriage of group A streptococcus in the Gambia: a posthoc analysis of a double-blind randomized placebo-controlled trial. BMC Infect Dis. 2022 Jan 29;22(1):103. doi: 10.1186/s12879-022-07080-4.
PubMed 35093029Camara B, Oluwalana C, Miyahara R, Lush A, Kampmann B, Manneh K, Okomo U, D'Alessandro U, Roca A. Stillbirths, Neonatal Morbidity, and Mortality in Health-Facility Deliveries in Urban Gambia. Front Pediatr. 2021 Feb 15;9:579922. doi: 10.3389/fped.2021.579922. eCollection 2021.
PubMed 33659227Bojang A, Baines SL, Camara B, Guerillot R, Donovan L, Marques RS, Secka O, D'Alessandro U, Bottomley C, Howden BP, Roca A. Impact of Intrapartum Oral Azithromycin on the Acquired Macrolide Resistome of Infants' Nasopharynx: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3222-3225. doi: 10.1093/cid/ciaa609.
PubMed 32445474Bojang A, Baines SL, Donovan L, Guerillot R, Stevens K, Higgs C, Bottomley C, Secka O, Schultz MB, Goncalves da Silva A, Seemann T, Stinear TP, Roca A, Howden BP. Genomic investigation of Staphylococcus aureus recovered from Gambian women and newborns following an oral dose of intra-partum azithromycin. J Antimicrob Chemother. 2019 Nov 1;74(11):3170-3178. doi: 10.1093/jac/dkz341.
PubMed 31424550Roca A, Camara B, Oluwalana C, Lette K, Bottomley C, D'Alessandro U. Long-lasting effect of oral azithromycin taken by women during labour on infant nutrition: Follow-up cohort of a randomized clinical trial in western Gambia. PLoS One. 2018 Oct 25;13(10):e0206348. doi: 10.1371/journal.pone.0206348. eCollection 2018.
PubMed 30359447Bojang A, Camara B, Jagne Cox I, Oluwalana C, Lette K, Usuf E, Bottomley C, Howden BP, D'Alessandro U, Roca A. Long-term Impact of Oral Azithromycin Taken by Gambian Women During Labor on Prevalence and Antibiotic Susceptibility of Streptococcus pneumoniae and Staphylococcus aureus in Their Infants: Follow-up of a Randomized Clinical Trial. Clin Infect Dis. 2018 Sep 28;67(8):1191-1197. doi: 10.1093/cid/ciy254.
PubMed 29608659Burr SE, Camara B, Oluwalana C, Bojang E, Bottomley C, Bojang A, Bailey RL, D'Alessandro U, Roca A. Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double-blind, randomized trial. BMC Infect Dis. 2017 Dec 28;17(1):799. doi: 10.1186/s12879-017-2909-4.
PubMed 29282015Roca A, Oluwalana C, Bojang A, Camara B, Kampmann B, Bailey R, Demba A, Bottomley C, D'Alessandro U. Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial. Clin Microbiol Infect. 2016 Jun;22(6):565.e1-9. doi: 10.1016/j.cmi.2016.03.005. Epub 2016 Mar 26.
PubMed 27026482Salman S, Davis TM, Page-Sharp M, Camara B, Oluwalana C, Bojang A, D'Alessandro U, Roca A. Pharmacokinetics of Transfer of Azithromycin into the Breast Milk of African Mothers. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1592-9. doi: 10.1128/AAC.02668-15.
PubMed 26711756Roca A, Oluwalana C, Camara B, Bojang A, Burr S, Davis TM, Bailey R, Kampmann B, Mueller J, Bottomley C, D'Alessandro U. Prevention of bacterial infections in the newborn by pre-delivery administration of azithromycin: Study protocol of a randomized efficacy trial. BMC Pregnancy Childbirth. 2015 Nov 19;15:302. doi: 10.1186/s12884-015-0737-3.
PubMed 26585192
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01800942
- Acronym / sponsor ID
- PregnAnZI / SCC1282
- Conditions
- Neonatal Infection
- Keywords
- prevention, bacterial infection, neonates, women in labour, Azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Feb 2013 (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.
The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.
Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.
Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.
If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.
The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.
The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.
This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Azithromycin and Placebo830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo. A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour. |
| Azithromycin | Experimental | Drug: Azithromycin and Placebo830 women will be recruited into the study and randomised in a ratio of 1:1 per study arm to receive either Azithromycin or placebo. A single dose of Azithromycin 2g or Placebo will be given orally to pregnant women in labour. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women (aged 18 to 45 years)
- in labour
- attending a health centre in western Gambia for delivery
Key exclusion criteria (10 listed)
- Known HIV infection.
- Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician.
- Planned travelling out of the catchment area during the following 2 months (follow-up period)
- Planned caesarean section
- Known required referral
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 |
|---|---|---|
| Azithromycin and PlaceboA single oral dose of 2g of Azithromycin will be given to the women in labour | Drug | Azithromycin, Placebo |
Primary outcome
the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus
Time frame: 6 days
The primary outcome is the prevalence of nasopharyngeal carriage of the newborn at the age of six days for any of the following bacteria: 1) Group B Streptococci, 2) S.pneumoniae and 3) S.aureus.
1 secondary outcome
Vaginal bacterial Group B Streptococci(GBS), S.pneumoniae and S.aureus) carriage at day six post-delivery. Vaginal bacterial (GBS, S.pneumoniae and S.aureus) carriage at day 8-10 post-delivery
Time frame: 6-13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 35093029Jagne I, Keeley AJ, Bojang A, Camara B, Jallow E, Senghore E, Oluwalana C, Bah SY, Turner CE, Sesay AK, D'Alessandro U, Bottomley C, de Silva TI, Roca A. Impact of intra-partum azithromycin on carriage of group A streptococcus in the Gambia: a posthoc analysis of a double-blind randomized placebo-controlled trial. BMC Infect Dis. 2022 Jan 29;22(1):103. doi: 10.1186/s12879-022-07080-4.
- Derived from this study: PubMed 33659227Camara B, Oluwalana C, Miyahara R, Lush A, Kampmann B, Manneh K, Okomo U, D'Alessandro U, Roca A. Stillbirths, Neonatal Morbidity, and Mortality in Health-Facility Deliveries in Urban Gambia. Front Pediatr. 2021 Feb 15;9:579922. doi: 10.3389/fped.2021.579922. eCollection 2021.
- Derived from this study: PubMed 32445474Bojang A, Baines SL, Camara B, Guerillot R, Donovan L, Marques RS, Secka O, D'Alessandro U, Bottomley C, Howden BP, Roca A. Impact of Intrapartum Oral Azithromycin on the Acquired Macrolide Resistome of Infants' Nasopharynx: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3222-3225. doi: 10.1093/cid/ciaa609.
- Derived from this study: PubMed 31424550Bojang A, Baines SL, Donovan L, Guerillot R, Stevens K, Higgs C, Bottomley C, Secka O, Schultz MB, Goncalves da Silva A, Seemann T, Stinear TP, Roca A, Howden BP. Genomic investigation of Staphylococcus aureus recovered from Gambian women and newborns following an oral dose of intra-partum azithromycin. J Antimicrob Chemother. 2019 Nov 1;74(11):3170-3178. doi: 10.1093/jac/dkz341.
- Derived from this study: PubMed 30359447Roca A, Camara B, Oluwalana C, Lette K, Bottomley C, D'Alessandro U. Long-lasting effect of oral azithromycin taken by women during labour on infant nutrition: Follow-up cohort of a randomized clinical trial in western Gambia. PLoS One. 2018 Oct 25;13(10):e0206348. doi: 10.1371/journal.pone.0206348. eCollection 2018.
- Derived from this study: PubMed 29608659Bojang A, Camara B, Jagne Cox I, Oluwalana C, Lette K, Usuf E, Bottomley C, Howden BP, D'Alessandro U, Roca A. Long-term Impact of Oral Azithromycin Taken by Gambian Women During Labor on Prevalence and Antibiotic Susceptibility of Streptococcus pneumoniae and Staphylococcus aureus in Their Infants: Follow-up of a Randomized Clinical Trial. Clin Infect Dis. 2018 Sep 28;67(8):1191-1197. doi: 10.1093/cid/ciy254.
- Derived from this study: PubMed 29282015Burr SE, Camara B, Oluwalana C, Bojang E, Bottomley C, Bojang A, Bailey RL, D'Alessandro U, Roca A. Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double-blind, randomized trial. BMC Infect Dis. 2017 Dec 28;17(1):799. doi: 10.1186/s12879-017-2909-4.
- Derived from this study: PubMed 27026482Roca A, Oluwalana C, Bojang A, Camara B, Kampmann B, Bailey R, Demba A, Bottomley C, D'Alessandro U. Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial. Clin Microbiol Infect. 2016 Jun;22(6):565.e1-9. doi: 10.1016/j.cmi.2016.03.005. Epub 2016 Mar 26.
- Derived from this study: PubMed 26711756Salman S, Davis TM, Page-Sharp M, Camara B, Oluwalana C, Bojang A, D'Alessandro U, Roca A. Pharmacokinetics of Transfer of Azithromycin into the Breast Milk of African Mothers. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1592-9. doi: 10.1128/AAC.02668-15.
- Derived from this study: PubMed 26585192Roca A, Oluwalana C, Camara B, Bojang A, Burr S, Davis TM, Bailey R, Kampmann B, Mueller J, Bottomley C, D'Alessandro U. Prevention of bacterial infections in the newborn by pre-delivery administration of azithromycin: Study protocol of a randomized efficacy trial. BMC Pregnancy Childbirth. 2015 Nov 19;15:302. doi: 10.1186/s12884-015-0737-3.
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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.
Anna Roca, PhD principal investigator
Medical Research Council Unit, The Gambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Neonatal Infection, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 22 Mar 2018. 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 The Gambia. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800942, which also lists 10 linked publications.
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 22 Mar 2018.