Establishment of a Clinical Trial Unit in Mavalane, Maputo, in Mozambique

Main study objective:

To assess the feasibility to perform a TB clinical trial in Maputo, Mozambique, by screening, examining,enrollment, follow-up and data collection of TB patients sent for TB treatment as well as TB suspects who are sent for smear microscopy to the TB clinic at the Mavalane health center.

Screening of study patients:

After consenting, each study participant (with confirmed or suspected TB) will be screened for TB with smear microscopy after Ziehl-Neelsen staining and Xpert MTB/RIF assay. In patients with signs of extrapulmonary TB manifestation, specimen collection other than sputum are to be decided by the treating physician in the patient' s best interest, to establish TB diagnosis by using smear microscopy and/or Xpert MTB/RIF assay. Patients without a positive Xpert MTB/RIF-assay result will not continue in the study but will be referred to the National TB Program for further evaluation and treatment. In patients with a positive Xpert MTB/RIF result in any specimen anti TB treatment will be commenced according to the National Guidelines. All TB positive study participants will be followed up until 6 months after TB treatment initiation.

Study methods:

Follow up visits will occur at week 1, 2, 4, 8, 12, 17 and 26 after commencement of TB therapy. An optional visit will be performed in selected patients at week 52 in order to confirm cure of TB disease. At each study visit, a clinical investigation will be performed and a medical questionnaire will be completed for each participant. Further, sputum and urine samples will be collected for the evaluation of the new TB diagnostics. A chest x-ray will be performed and blood for HIV testing, CD4 count, biochemistry and full blood picture will be collected at baseline only or when medically indicated during the course of the study.

Data recording and analysis:

The study will follow ethical principles as outlined in the declaration of Helsinki and its revisions (last in 2008) and will be performed in compliance with the guidelines of Good Clinical, Laboratory (GCLP) and Clinical Data Management Practice (GCDMP). All essential documents will be archived for 3 years. All patient information will be treated in a strictly confidential manner and will be linked to a unique ID number and not to personal identifiers. Data will be collected on paper CRFs, which will be entered into a secured clinical data management system, for which daily backups will be done. Double data entry will minimize data entry errors, and full data validation and cleaning process will be employed.

Inclusion criteria

• >/= 18 years old
• Able and willing to give informed consent to study participation, including HIV-testing
• Positive TB result by Xpert MTB/RIF performed at the study clinic

Exclusion criteria

• TB treatment in the last 6 months
• Abandoned TB treatment at any time point in the past
• Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
• Karnofsky index below 50%