Skip to main content

Table 2 Inclusion and exclusion criteria

From: The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis

Study selection criteria

Definition

Clinical inclusion criteria

Age ≥ 14 years and ≤ 65 years

Male or non-pregnant woman of childbearing-potential using an approved, effective method of contraception before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo

Able to give informed consent/assent to participate in the trial

Resident in an LF endemic area for five years (> 2 years for TAKeOFF)

Body weight ≥ 40 kg

Lymphoedema of at least one limb Stage 1-6 measured on a 7-point scale. (Stage 2 or 3 for podoconiosis)

Ability to use established standardized methods of hygiene and effectively applying it prior to initiation of drug treatment

No evidence of severe or systemic co-morbidities (except for features of filarial disease)

Normal laboratory profile (type of investigations and normal limits in the case of haematological abnormalities are site-specific)

Consent to storage of blood samples for further study (site specific)

Negative pregnancy test

Clinical exclusion criteria

No lymphoedema or lymphoedema stage 7

Age < 14 years or > 65 years

Body weight < 40 kg

Pregnant or breastfeeding women

Women of childbearing potential not using an agreed method of contraception

Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease

Alcohol or drug abuse

History of adverse reactions to doxycycline or other tetracyclines

Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator

History of photosensitivity reactions after taking drugs

Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue

Concomitant medication with other antibiotics than doxycycline and not able to discontinue

Concomitant medication with diuretics or sulfonylurea or coumarin

Laboratory exclusion criteria

Haemoglobin < 8 g/dl

Neutrophil count < 1100/mm3

Platelet count < 100,000/mm3

Creatinine > 2 times upper limit of normal

AST (GOT), ALT (GPT), gamma-GT > 2 times upper limit of normal

Positive urine pregnancy test