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Mortality Reduction After Oral Azithromycin: Morbidity Study (MORDORMorb)

15. März 2021 aktualisiert von: University of California, San Francisco

Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Morbidity Study

The long-term goal of this study is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and increasing growth, and for the potential selection of antibiotic resistance. The investigators propose a set of 3 cluster-randomized trials in Malawi, Niger, and Tanzania comparing communities randomized to oral azithromycin with those randomized to placebo. To assess the generalizability of the intervention, investigators will monitor for antibiotic resistance, which could potentially limit adoption of mass antibiotic treatments. The investigators will also assess several measures of infectious diseases. The investigators hypothesize that mass azithromycin treatments will reduce childhood morbidity and will be accompanied by an acceptable level of antibiotic resistance.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The investigators will assess childhood infectious disease morbidity and macrolide resistance over two years, comparing communities where children aged 1-60 months receive biannual oral azithromycin to communities where the children receive biannual oral placebo.

Randomization of Treatment Allocation. In each site, 30 communities within a contiguous area of 300,000 to 600,000 individuals will be randomized into the azithromycin or placebo arm. The investigators will use a simple random sample separately for each study site, but without stratification or block randomization within the site. These communities are being randomized from the same pool of communities eligible for a sister trial (Mortality Reduction After Oral Azithromycin (MORDOR) - Morbidity Study).

Specific Aims

Specific Aim 1: To assess whether macrolide resistance is greater in a population-based community sample of pre-school children, or in a clinic-based sample of ill pre-school children

Specific Aim 2: To assess whether biannual mass azithromycin treatments of pre-school children can eliminate ocular chlamydia in a hypoendemic area

Specific Aim 3: To assess the diversity of the microbiome of the nasopharynx, nares, conjunctiva, and gastrointestinal tract

Studientyp

Interventionell

Einschreibung (Tatsächlich)

72000

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Malawi
      • Blantyre, Malawi
        • College of Medicine at the University of Malawi, Blantyre
  • Niger
      • Niamey, Niger
        • The Carter Center, Niger
  • Tansania
      • Kongwa, Tansania
        • Kongwa Trachoma Project
  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94143-0944
        • UCSF Proctor Foundation
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21205
        • Johns Hopkins University
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich
        • London School of Hygiene & Tropical Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Monat und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Communities:

  • The community location in target district.
  • The community leader consents to participation in the trial
  • The community's estimated population is between 200-2,000 people.
  • The community is not in an urban area.

Individuals (Intervention):

- Children-treated arms (all 3 sites): All children aged 1-60 months (up to but not including the 5th birthday), as assessed at the most recent biannual census

Individuals (Examination & Sample Collection):

  • All swabs, blood tests, and stool samples: A random sample of children aged 1-60 months (up to but not including the 5th birthday) based on the previous census
  • Anthropometric measurements: All children aged 1-60 months (up to but not including the 5th birthday) will have anthropometric measurements assessed.
  • Nasopharyngeal swabs in untreated children: A random sample of individuals aged 7 - 12 years (7th birthday up to but not including the 12th birthday), as assessed from the previous census
  • Clinic-based nasopharyngeal swabs: All children aged 1-60 months (up to but not including the 5th birthday) who present to a local health clinic in the study area and report symptoms of a respiratory infection

Exclusion Criteria:

Individuals:

  • Pregnant women
  • All those who are allergic to macrolides or azalides
  • Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Biannual mass oral azithromycin

Comparison of childhood infectious and nutritional morbidity in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years

Morbidity monitoring:

Collect swabs (nasopharyngeal, nasal, conjunctival), blood samples, (thick/thin blood smears, hemoglobin, dried blood spots), and stool samples from 40 randomly selected children aged 1 month to 60 months per community; collect swabs (nasopharyngeal) from 40 randomly selected children aged 7-12 years per community.

Anthropometry for all children aged 1 to 60 months per community.

Collect nasopharyngeal swabs from all children aged 1-60 months who are seen at a local health clinic and have a respiratory complaint.
Arzneimittel: Azithromycin
Biannual mass oral azithromycin to children
Andere Namen:
  • Zithromax
Placebo-Komparator: Biannual mass oral placebo

Comparison of childhood infectious and nutritional morbidity in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

Collect swabs (nasopharyngeal, nasal, conjunctival), blood samples, (thick/thin blood smears, hemoglobin, dried blood spots), and stool samples from 40 randomly selected children aged 1 month to 60 months per community; collect swabs (nasopharyngeal) from 40 randomly selected children aged 7-12 years per community

Anthropometry for all children aged 1 to 60 months per community

Collect nasopharyngeal swabs from all children aged 1-60 months who are seen at a local health clinic and have a respiratory complaint
Arzneimittel: Placebo
Biannual mass oral placebo to children

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months
Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months
Zeitfenster: 24 months
MORDOR Malawi and Niger. Please note: Each outcome will be analyzed separately for each study site.
24 months
Height over time in children aged 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi and Niger Please note: Each outcome will be analyzed separately in each of the two study sites.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Weight for Height over time in children aged 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi and Niger Please note:Each outcome will be analyzed separately in each of the two study sites.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Density of asexual stages and gametocytes, in children 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi and Niger Please note: Each outcome will be analyzed separately in each of the two study sites.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Hemoglobin concentration and presence of anemia (hemoglobin <11 g/dL) in children 1-60 months
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Genetic determinants of macrolide resistance in the nasopharynx (eg pneumococcal) in individuals 7-12 years of age
Zeitfenster: 24 months
MORDOR Niger
24 months
Genetic determinants of macrolide resistance in the nasopharynx (eg pneumococcal) in individuals 1-60 month olds seen in local health clinics for a respiratory complaint
Zeitfenster: 24 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
24 months
Rates of acute respiratory illness among children 1-60 months.
Zeitfenster: 6-24 months after baseline
MORDOR Tanzania
6-24 months after baseline
Presence of the trachoma grades "follicular trachoma" (TF) and "intense inflammatory trachoma" (TI), as defined by the World Health Organization (WHO) simplified grading system, in children 1-60 months
Zeitfenster: 24 months
MORDOR Malawi and Niger Please note: Each outcome will be analyzed separately for each study site.
24 months
Rates of diarrhea among children (1-60 months)
Zeitfenster: 6-24 months after baseline
MORDOR Tanzania
6-24 months after baseline
Proportion of rectal/stool isolates with evidence of resistance (in for example E.coli) to macrolides and other antibiotics commonly used to treat pediatric infections among children 1-60 months
Zeitfenster: 6-24 months after baseline; Niger will also report outcomes at 48 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
6-24 months after baseline; Niger will also report outcomes at 48 months
Proportions of E. coli isolates resistant to macrolides and to antibiotics commonly used to treat pediatric infections among children 1-60 months hospitalized for pneumonia and diarrhea.
Zeitfenster: 6-24 months after baseline
MORDOR Tanzania
6-24 months after baseline
Studies of intestinal permeability and inflammation, microbial translocation, and immune activation assessed through venous sampling of children 6 months
Zeitfenster: 5 x over 24 weeks after baseline
MORDOR Malawi
5 x over 24 weeks after baseline
Studies of intestinal permeability and inflammation, microbial translocation, and immune activation assessed through urine samples for L:M ratios of children 6 months
Zeitfenster: 5 x over 24 weeks after baseline
MORDOR Malawi
5 x over 24 weeks after baseline
Studies of intestinal permeability and inflammation, microbial translocation, and immune activation assessed through stool (fecal neopterin) of children 6 months
Zeitfenster: 5 x over 24 weeks after baseline
MORDOR Malawi
5 x over 24 weeks after baseline
Nasopharyngeal pneumococcal evidence of beta lactam and macrolide resistance in in children 1-60 months as measured by RNA-sequencing of the resistome
Zeitfenster: Tanzania will report outcomes at 6-24 months. Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Tanzania will report outcomes at 6-24 months. Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months
Nasopharyngeal pneumococcal macrolide resistance determinants (eg erythromycin ribosomal methylase B and mefA), serotype, and multilocus sequence type in children 1-60 months
Zeitfenster: 24 months
MORDOR Niger
24 months
Microbiome in the stool, nasopharynx, nares, and conjunctiva in children aged 1-59 months, as measured using next generation sequencing. Arms will be compared using Euclidean distance and diversity compared using Simpson's index.
Zeitfenster: 24 months

Investigators will examine the effects of mass azithromycin (pre-treatment and post-treatment) on the human microbiome of African children by performing metagenomic experiments.

MORDOR Niger
24 months
Microbial diversity in the intestinal microbiomes of children aged 1-60 months as measured by using next generation sequencing
Zeitfenster: 24 months

Investigators will examine the effects of mass azithromycin (pre-treatment and post-treatment) on the human microbiome of African children by performing metagenomic experiments.

MORDOR Malawi
24 months
Serology for exposure to exotic pathogens of children aged 1-60 months as measured by lateral flow assays or Multiplex bead array
Zeitfenster: 24 months
MORDOR Malawi
24 months
Head circumference over time in children aged 1-60 months
Zeitfenster: 24 months
MORDOR Malawi
24 months
Knee-heel length over time in children aged 1-60 months
Zeitfenster: 24 months
MORDOR Malawi
24 months
Resistance (in E.coli phenotypically or genetic determinants) in stool of children aged 1-60 months.
Zeitfenster: Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.
Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months
Prevalence of carriage of a panel of gastrointestinal parasites (Ancylostoma duodenale, Necator americanus, Ascaris lumbricoides, Trichuris trichiura, Giardia lamblia, Cryptosporidium hominis) of children aged 1-60 months
Zeitfenster: Baseline
MORDOR Malawi
Baseline
Prevalence of helicobacter pylori of children aged 1-60 months
Zeitfenster: Baseline
MORDOR Malawi
Baseline
Antibody response to enteric pathogens and malaria measured with a multiplex bead assay from dried blood spots collected from children 1 - 59 months
Zeitfenster: Niger will report outcomes at 36, 48 and 60 months
MORDOR Niger
Niger will report outcomes at 36, 48 and 60 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Mitarbeiter

London School of Hygiene and Tropical Medicine
Johns Hopkins University
Bill and Melinda Gates Foundation

Ermittler

  • Studienleiter: Elodie J Lebas, RN, University of California, San Francisco

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2014

Primärer Abschluss (Tatsächlich)

27. August 2020

Studienabschluss (Tatsächlich)

27. August 2020

Studienanmeldedaten

Zuerst eingereicht

24. Januar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Januar 2014

Zuerst gepostet (Schätzen)

29. Januar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OPP1032340-B

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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