{"id":155,"date":"2021-03-21T13:51:19","date_gmt":"2021-03-21T13:51:19","guid":{"rendered":"http:\/\/localhost\/?page_id=155"},"modified":"2025-01-31T08:58:55","modified_gmt":"2025-01-31T08:58:55","slug":"materials","status":"publish","type":"page","link":"https:\/\/lakana.org\/?page_id=155","title":{"rendered":"Materials"},"content":{"rendered":"\n

The trial metadata are available for downloading both in English and in French.<\/p>\n\n\n\n

The English versions are available below.<\/p>\n\n\n\n

The French versions are available here<\/a>.<\/p>\n\n\n


<\/p>\n

Protocol<\/h2>\n

<\/p>\n

<\/p>\n

The current version of the protocol is here:<\/p>\n

<\/p>\n

<\/p>\n

LAKANA Protocol (Version 7.0 2024-11-13)<\/a><\/div>\n
\u00a0<\/div>\n

Statistical Analysis Plan<\/h2>\n

The current version of the SAP is here::<\/p>\n

LAKANA SAP (Version 3.0 2025-01-22)<\/a><\/div>\n
\u00a0<\/div>\n

Data collection forms<\/h2>\n

<\/p>\n

<\/p>\n

Current versions of the data collection forms are here:<\/p>\n

<\/p>\n

<\/p>\n

Form 01a: Compound enumeration (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 01b: Household enumeration (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 01c: Adult enumeration (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 01d: Child enumeration (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 01e: Household previous mortality (Version 1.0 – 2022-07-06<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 01f: Household consent (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 02: Child treatment (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 02a: Child re-treatment (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 02b: Child treatment at health facility (sub-study) (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 03: Immunization history (Version 2.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 04: Household assets (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 05: Water sanitation and hygiene (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 06: Vital status (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 07: Anthropometrics (Version 1.0 – 2022-07-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 08: Morbidity symptoms (Version 1.0 – 2021-03-09)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 09: Adverse Events (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 10a: Initial report of a suspected serious adverse event – part A (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 10b: Initial report of a suspected serious adverse event – part B (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 11: Follow-up report of a suspected serious adverse event (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 12: Conclusion of a suspected serious adverse event (Version 1.0 – 2020-10-08)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 13: Biological sample collection (Version 1.0 – 2021-03-09)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Form 13c: Biological sample collection (Growth study) (Version 1.0 – 2022-08-30)<\/a><\/div>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

Standard operating procedures for data collection<\/h2>\n

<\/p>\n

<\/p>\n

Current versions of the standard operating procedures are here:<\/p>\n

<\/p>\n

<\/p>\n

Admin-01: Communication (Version 1.0 – 2020-03-29)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Admin-02: Writing and managing an SOP (Version 1.0 – 2020-08-18)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Admin-03: Study documentation (Version 1.0 – 2020-09-24)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Data-01: Data Storage Access Backup and Editing (Version 2.0 2024-10-09)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Data-02: Preparation for interim analysis (Version 1.0 2023-06-13)<\/a><\/div>\n
\u00a0<\/div>\n
Data-03: Opening the trial code (Version1.0 2025-01-22)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Pharm-01: Drug management (Version 5.0 – 2023-12-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Prep-01: Allocation of treatment codes to participating villages (Version 1.0 – 2020-08-25)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Prep-02: Scheduling village visits (Version 2.0 – 2023-05-31)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Proc-01: Provision of study drug (Version 5.0 – 2020-11-17)<\/a><\/div>\n
\u00a0<\/div>\n
\n
Proc-02: SAE Reporting Recording and Notification (Version 4.0 – 2023-06-21)<\/a><\/div>\n<\/div>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

Proc-13: Protocol deviation reporting (Version 2.0 – 2023-12-11)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Safety-01: Hygiene and PPE use in the context of Covid-19 (Version 2.0 – 2020-10-20)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Visit-01: Conducting the enrolment visit (Version 3.0 – 2020-10-20)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Visit-02: Conducting subsequent visits (Version 2.0 – 2023-11-06)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Visit-09: Conducting the close-out visit (Version 1.0 – 2023-01-31)<\/a><\/div>\n
\u00a0<\/div>\n
RES 01-Seeking_coauthor_input_for_manuscripts_v1.0_2022-06-27)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Current versions of the standard operating procedures specific to the antimicrobial resistance and LAKANA sub-studies\u00a0 are here:<\/p>\n

<\/p>\n

<\/p>\n

Subvisit-01: AMR Conducting the enrolment visit (Version 2.0 – 2021-04-20)<\/a><\/div>\n
\u00a0<\/div>\n
Subvisit-04: Conducting Mechanistic Sub-study Visit 04 (Version 1.0 – 2022-03-15)<\/a><\/div>\n
\u00a0<\/div>\n
Subvisit-04b: Conducting Rainy season Mechanistic Sub-study Visit 04 (Version 1.0 – 2023-07-05)<\/a><\/div>\n
\n

<\/p>\n

<\/p>\n

Subvisit-06\u201308: Conducting AMR-MDA 6, 7 and 8 visit (Version 1.0 – 2022-11-15)<\/a><\/div>\n<\/div>\n
\u00a0<\/div>\n
Subvisit-09: Conducting Sub-study Visit 09 (Version 1.0 – 2023-07-05)<\/a><\/div>\n
\u00a0<\/div>\n
Subvisit-05: Conducting Mechanistic Sub-study Visit 05 (Version 1.0 – 2022-06-22)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-03: AMR Rectal swab processing (Version 2.0 – 2021-04-20)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-04: AMR NPS processing (Version 2.0 – 2021-04-20)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-05: E.coli culture (Version 1.0 – 2022-06-22)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-06: S.pneumoniae culture (Version 1.0 – 2022-06-22)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-07: E.coli AMR (Version 1.0 – 2022-06-22)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-08: S.pneumoniae AMR (Version 1.0 – 2022-06-22)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-09: Processing of whole stool specimen (Version 1.0 – 2022-03-15)<\/a><\/div>\n
\u00a0<\/div>\n
Lab-10: Processing of DBS samples (Version 1.0 – 2022-03-15)<\/a><\/div>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

Lab-11: Processing of blood, urine and stool samples (Version 1.0 – 2022-11-15)<\/a><\/div>\n
\u00a0<\/div>\n
\n
Lab-12: Extraction of E.coli DNA (Version 1.0 – 2023-07-05)<\/a><\/div>\n
\u00a0<\/div>\n<\/div>\n
Proc-03: Performing anthropometric measurements (Version 1.0 – 2022-11-15)<\/a><\/div>\n
\u00a0<\/div>\n
Proc-04: AMR Preparation of sample collection bags (Version 2.0 – 2021-04-20)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Proc-05: AMR Collection of rectal swab samples (Version 1.0 – 2021-03-23)<\/a><\/div>\n

<\/p>\n

<\/p>\n

Proc-06: AMR Collection of nasopharyngeal swab samples (Version 1.0 – 2021-03-23)<\/a><\/div>\n
\u00a0<\/div>\n
\n
Proc-07: Preparation of sample collection material for DBS, stool samples, and CRP and Hb (Version 1.0 – 2022-03-15)<\/a><\/div>\n
\u00a0<\/div>\n
Proc-08: Measuring CRP and Hb, collection of DBS and stool samples (Version 1.0 – 2022-03-15)<\/a><\/div>\n
\n
\n
\u00a0<\/div>\n
Proc-09: Collecting blood, urine and stool sample at pop-up facility (Version 1.0 – 2022-11-15)<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

<\/p>","protected":false},"excerpt":{"rendered":"

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 7.0 2024-11-13) \u00a0 Statistical Analysis Plan The current version of the SAP is here:: LAKANA SAP (Version 3.0…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-155","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/pages\/155","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lakana.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=155"}],"version-history":[{"count":93,"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/pages\/155\/revisions"}],"predecessor-version":[{"id":978,"href":"https:\/\/lakana.org\/index.php?rest_route=\/wp\/v2\/pages\/155\/revisions\/978"}],"wp:attachment":[{"href":"https:\/\/lakana.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=155"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}