Information about the LAKANA COVID-19 public health interventions and surveillance activities →

Materials

The trial metadata are available for downloading both in English and in French.

The English versions are available below.

The French versions are available here.


Protocol

The current version of the protocol is here:

LAKANA Protocol (Version 4.0 2022-06-27)

Data collection forms

Current versions of the data collection forms are here:

Form 01a: Compound enumeration (Version 1.0 – 2022-07-06)

Form 01b: Household enumeration (Version 1.0 – 2022-07-06)

Form 01c: Adult enumeration (Version 1.0 – 2022-07-06)

Form 01d: Child enumeration (Version 1.0 – 2022-07-06)

Form 01e: Household previous mortality (Version 1.0 – 2022-07-06

Form 01f: Household consent (Version 1.0 – 2022-07-06)

Form 02: Child treatment (Version 1.0 – 2022-07-06)

Form 02a: Child re-treatment (Version 1.0 – 2020-10-08)

Form 02b: Child treatment at health facility (sub-study) (Version 1.0 – 2022-07-06)

Form 03: Immunisation history (Version 2.0 – 2022-07-06)

Form 04: Household assets (Version 1.0 – 2022-07-06)

Form 05: Water sanitation and hygiene (Version 1.0 – 2022-07-06)

Form 06: Vital status (Version 1.0 – 2022-07-06)

Form 07: Anthropometrics (Version 1.0 – 2022-07-06)

Form 08: Morbidity symptoms (Version 1.0 – 2021-03-09)

Form 09: Adverse Events (Version 1.0 – 2020-10-08)

Form 10a: Initial report of a suspected serious adverse event – part A (Version 1.0 – 2020-10-08)

Form 10b: Initial report of a suspected serious adverse event – part B (Version 1.0 – 2020-10-08)

Form 11: Follow-up report of a suspected serious adverse event (Version 1.0 – 2020-10-08)

Form 12: Conclusion of a suspected serious adverse event (Version 1.0 – 2020-10-08)

Form 13: Biological sample collection (Version 1.0 – 2021-03-09)

Form 13c: Biological sample collection (Growth study) (Version 1.0 – 2022-08-30)

Form 14: Protocol deviation – individual level (Version 2.0 – 2021-06-22)

Form 15: Protocol deviation – site level (Version 2.0 – 2021-06-22)

Standard operating procedures for data collection

Current versions of the standard operating procedures are here:

Admin-01: Communication (Version 1.0 – 2020-03-29)

Admin-02: Writing and managing an SOP (Version 1.0 – 2020-08-18)

Admin-03: Study documentation (Version 1.0 – 2020-09-24)

Data-01: Data Storage Access Backup and Editing (Version 1.0 2022-11-09)

Data-02: Preparation for interim analysis (Version 1.0 2023-06-14)

Pharm-01: Drug management (Version 4.0 – 2021-05-11)

Prep-01: Allocation of treatment codes to participating villages (Version 1.0 – 2020-08-25)

Prep-02: Scheduling village visits (Version 1.0 – 2020-08-18)

Proc-01: Provision of study drug (Version 5.0 – 2020-11-17)

Proc-02: SAE reporting, recording and notification (Version 2.0 – 2020-10-07)

Proc-03: Performing anthropometric measurements (Version 1.0 – 2022-11-15)

Proc-09: Collecting blood, urine and stool sample at pop-up facility (Version 1.0 – 2022-11-15)

Proc-13: Protocol deviation reporting (Version 1.0 – 2021-06-22)

Safety-01: Hygiene and PPE use in the context of Covid-19 (Version 2.0 – 2020-10-20)

Visit-01: Conducting the enrolment visit (Version 3.0 – 2020-10-20)

Visit-02: Conducting subsequent visits (Version 1.0 – 2021-03-03)

Visit-09: Conducting the close-out visit (Version 1.0 – 2023-01-31)
 

Current versions of the standard operating procedures specific to the antimicrobial resistance study are here:

Lab-03: AMR Rectal swab processing (Version 2.0 – 2021-04-20)

Lab-04: AMR NPS processing (Version 2.0 – 2021-04-20)

Lab-11: Processing of blood, urine and stool samples (Version 1.0 – 2022-11-15)

Proc-04: AMR Preparation of sample collection bags (Version 2.0 – 2021-04-20)

Proc-05: AMR Collection of rectal swab samples (Version 1.0 – 2021-03-23)

Proc-06: AMR Collection of nasopharyngeal swab samples (Version 1.0 – 2021-03-23)

Subvisit-01: AMR Conducting the enrolment visit (Version 2.0 – 2021-04-20)

Subvisit-06–08: Subvisit 06–08: Conducting AMR-MDA 6, 7 and 8 visit (Version 1.0 – 2022-11-15)
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