Multidrug Resistant Shigella Infection in Bangladesh
Fjalë kyçe
Abstrakt
Përshkrim
2000 suspected Shigella cases will be recruited from International Centre for Diarrhoeal Disease Research hospital, Dhaka who are presenting with diarrhea at the hospital. A stool sample will be collected from the participants after consenting by the study staff. Stool microscopy will be performed to see the white blood cells(WBC) and red blood cells (RBC). If WBC > 10 HPF (4) with any RBC present, culture will be performed from this stool to identify Shigella. Such patients with invasive diarrhea are treated with azithromycin per local standard of care. Enrolled participant will be invited for further follow up when culture from the stool is Shigella positive. Minimal inhibitory concentration (MIC) testing of Shigella isolates and Molecular testing of Shigella isolates will be performed from Shigella cultures. This is an observational study. This study does not provide any treatment to the study participants; they will receive treatment as per International Centre for Diarrhoeal Disease Research Dhaka hospital guidelines. We will then examine the effect of the azithromycin minimal inhibitory concentration on clinical outcome.
Datat
| Verifikuar së fundmi: | 12/31/2018 |
| Paraqitur së pari: | 12/11/2018 |
| Regjistrimi i vlerësuar u dorëzua: | 12/12/2018 |
| Postuar së pari: | 12/18/2018 |
| Përditësimi i fundit i paraqitur: | 01/24/2019 |
| Përditësimi i fundit i postuar: | 01/28/2019 |
| Data e fillimit të studimit aktual: | 12/12/2018 |
| Data e vlerësuar e përfundimit primar: | 12/30/2019 |
| Data e vlerësimit të përfundimit të studimit: | 01/30/2020 |
Gjendja ose sëmundja
Faza
Kriteret e pranimit
| Gjinitë e pranueshme për studim | All |
| Metoda e marrjes së mostrës | Probability Sample |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | Inclusion Criteria: - diarrheal illness less than 96 hours duration - microscopic evidence of inflammatory diarrhea - plus mucus in stool - plus abdominal pain/cramps - Subject or parents or legal guardian willing to come for follow up at hospital or allow study staff for home visit - residence in Dhaka region - presentation during daytime hours Exclusion Criteria: • Not receiving treatment with azithromycin at enrolment |
Rezultati
Masat Kryesore të Rezultateve
1. Clinical outcome: resolution of diarrhea [Day 5]
Masat dytësore të rezultateve
1. Microbiologic outcome: Shigella negative cultures [Day 5]
2. Proportion of patients that have complications [day 5]
Masat e tjera të rezultateve
1. time to last unformed stool [Day 5]
2. fever [Day 5]
3. bloody stool [Day 5]
4. difference in invasion plasmid antigen H (ipaH) [Day 5]
